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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Amendment
The amendments filed on 12/22/2025 has been entered. Claim 1 has been amended claims 5, 8, and 13-20 have been withdrawn.
Accordingly, claims 1-20 are pending and under consideration.
Response to Arguments
Applicant’s arguments, filed 12/22/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. More particularly, Examiner had reconsidered Applicant’s cited paragraph [0163] of Fangrow for the teachings of “a space 695 for accepting a jacket (not shown) used to keep the sleeve members 603 in a closed configuration. The space 695 can be of particular utility when the jacket has a substantial length or otherwise comprises a large amount of material”; space 695 of Fangrow may not be capable of containing any accumulated leaked fluid because space 695 is reserved for a jacket, such as jacket 505 as seen in Fig. 12A. Therefore, the rejection has been withdrawn.
However, upon further search and consideration, a new ground(s) of rejection is made in view of Zinger et al. US 2009/0177177 A1 (previously cited) in view of Williams, JR. et al. US 20160161358 A1 (newly cited) and Wyatt et al. US 2011/0160701 A1 (previously cited), as cited in the IDS.
See rejection of claims below.
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 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al. US 2009/0177177 A1 (previously cited, hereinafter Zinger) in view of Williams, JR. et al. US 2016/0161358 A1 (newly cited, hereinafter Williams Jr) and Wyatt et al. US 2011/0160701 A1 (previously cited, hereinafter Wyatt), as cited in the IDS.
Regarding claim 1, Zinger discloses a vial adapter 10 (Fig. 1 – liquid drug transfer device 10) configured to withdraw a fluid from a fluid container 11 (Fig. 1 – vial 11, and Abstract – “Liquid drug transfer devices including a vial adapter designed for failsafe correct snap fitting on a medicinal vial for ensuring flow communication with the vial's interior”) with a syringe (Par. 17 – “The liquid drug transfer device 10… for receiving a syringe (not shown)…”), the vial adapter 10 (Fig. 1) comprising:
a wall 33 (Fig. 2 – top wall 33), a plurality of prongs 36, 37 (Fig. 2 – vial retention and guidance flex members 36, 37) extending distally from the wall 33 (Fig. 2, and Par. 17 – “…three non-adjacent axially directed vial retention flex members 36 and three non-adjacent axially directed vial guidance flex members 37 resiliently elastically attached to the top wall 33”), at least one of the plurality of prongs 36, 37 (Fig. 2) having a protruding inner flange 36C (Fig. 2 – inwardly protruding retention ribs 36C, and Par. 18 – “The vial retention flex members 36… are provided with circumferentially extending inwardly protruding vial retention ribs 36C”) configured to lock to a neck 26 (Fig. 2 – peripheral surface 26) of a fluid container 11 (Fig. 2 and Fig. 3D – ribs 36C hook onto the neck 26 of vial 11, and Par. 18 – “inwardly protruding vial retention ribs 36C for snap fitting over the vial opening 16…”);
a stake 38 (Fig. 2 – puncturing spike 38) projecting distally from the wall 33 (Fig. 2 – spike 38 extending away from wall 33 and towards the vial 11) to a beveled tip 39 (Fig. 2 – spike’s tip 39, and Par. 17 – “The puncturing spike 38 has a tip 39 with a flow aperture 41 theretowards”) and defining a length (Fig. 2 – the length of spike 38 is the distance from top wall 33 to tip 39), the stake 38 (Fig. 2) having a proximal end (Fig. 2 – the top side/the side with top wall 33) and a distal end (Fig. 2 – the bottom side/the side with tip 39), the stake 38 (Fig. 2) having at least one inlet 41 (Fig. 2 – flow aperture 41) at the distal end (Fig. 2 – aperture 41 is disposed at the bottom side of stake 38), the inlet 41 (Fig. 2) extending longitudinally along the length of the stake 38 (Fig. 2 – aperture 41 extends axially with the stake 38) toward the proximal end (Fig. 2 – aperture 41 spans from the distal end of stake 38 toward the top side/proximal end of stake 38);
a lumen L (see annotated Fig. 2 below – lumen L) extending from the at least one inlet 41 (Fig. 2 – lumen L extends from and connects with aperture 41) through the wall 33 (see annotated Fig. 2 below – lumen L traverses through the top wall 33), the lumen L (see annotated Fig. 2 below) defining an opening O in the wall 33 (see annotated Fig. 2 below – lumen L traverses through the top wall 3 via opening O); the lumen L (see annotated Fig. 2 below) being in fluid communication with the at least one inlet 41 (see annotated Fig. 2 below – lumen L and aperture 41 are fluidly connected); and,
an elongated body E (see annotated Fig. 2 below – elongated body E) extending proximally from the wall 33 (see annotated Fig. 2 below – elongated body E extends in the opposite direction of the members 37 from the top wall 33) defining a longitudinal cavity C (see annotated Fig. 2 below – longitudinal cavity C), the cavity C (see annotated Fig. 2 below) defining an inner wall W (see annotated Fig. 2 below – inner wall W of longitudinal cavity C) and a proximal opening PO (see annotated Fig. 2 below – proximal opening PO of longitudinal cavity C), the elongated body E (see annotated Fig. 2 below) including a connecting member 32 (Fig. 2 – Luer connector 32) configured to connect to a syringe connecting member (Par. 17 – “an upright female Luer connector 32 for receiving a syringe (not shown)…”).
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Annotated Fig. 2 of Zinger
However, Zinger does not explicitly disclose a wall having a distally facing circular protrusion and a circular trench, the circular trench being disposed within the circular protrusion, the circular protrusion and circular trench disposed concentrically to the wall, the circular trench configured to accumulate the fluid leaked from the fluid container during a withdrawal and prevent a spillage outside of the vial adapter, the inlet extending longitudinally along about 50% of the length of the stake toward the proximal end, the at least one inlet does not extend to the height of the circular protrusion; the lumen housing a needle cannula of the syringe, the needle cannula being in fluid communication with the at least one inlet.
Williams Jr, in the same field of endeavor of connector for fluid delivery system (Par. 57), teaches a wall (see annotated Fig. 4 below) having a distally facing circular protrusion (see annotated Fig. 4 below – annotated circular protrusion faces away from the connector 100 and towards the container 14) and a circular trench (see annotated Fig. 4 below), the circular trench (see annotated Fig. 4 below) being disposed within the circular protrusion (see annotated Fig. 4 below – the annotated circular trench is within the circular protrusion), the circular protrusion (see annotated Fig. 4 below) and circular trench (see annotated Fig. 4 below) disposed concentrically to the wall (see annotated Fig. 4 below – circular protrusion and circular trench share the same center axis of the wall), the circular trench (see annotated Fig. 4 below) configured to accumulate the fluid leaked from the fluid container 14 (Fig. 4 – container 14; Examiner notes that Fig. 4 shows a cross-sectional view of connector 100 with an opening partially above the annotated circular trench given that there is no hatch/cross shading surrounding the spike 106, thus capable of allowing accumulation of leaked fluid) during a withdrawal and prevent a spillage outside of the vial adapter 100 (Fig. 4 – connector 100, and Par. 57 – “Mechanical connector 100 defines a base 102 that is configured to be positioned around rim 104 of the container 14 so that fluid does not leak out between the connector and the container. Mechanical connector 100 also includes a spike 106 that is inserted into an aperture 108 defined by rim 104”).
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Annotated Fig. 4 of Williams Jr
Wyatt, in the same field of endeavor of vial adapter (Par. 17-18), teaches the lumen 18b (Fig. 1 – lumen 18b) housing a needle cannula 42 (Fig. 1 – syringe cannula 42) of the syringe 26 (Fig. 1 – syringe cannula assembly 26), the needle cannula 42 (Fig. 1) being in fluid communication with the at least one inlet (see annotated Fig. 1 below – inlet).
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Annotated Fig. 1 of Wyatt
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial adapter of Zinger to further include circular protrusion and circular trench as taught by Williams Jr, so that the fluid does not leak out between the connector and the container (Par. 57 of Williams Jr).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination and made the length of the inlet along about 50% of the length of the stake, in order to fit the particular procedure being done since this claimed dimension of the inlet does not change the inlet ability to introduce liquid into the stake’s lumen. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 45 of Applicant’s PG-Pub), the Federal Circuit 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. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Lastly, since Zinger’s device allows for coupling with a syringe (Par. 17) and its needle (Fig. 5), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial adapter of the combination to further incorporate the stake’s lumen housing a cannula needle as taught by Wyatt, in order to provide a means to withdraw drug from the vial into the syringe, which is then injected to the patient (Par. 7 of Wyatt).
Regarding claim 2, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. The combination Wyatt further discloses wherein the cavity C (see annotated Fig. 2 of Zinger above) further defines an inner surface W (see annotated Fig. 2 of Zinger above).
However, the combination does not explicitly disclose an inner tapered surface, the inner surface creates an interference fit with a needle hub on the syringe.
Wyatt, in the same field of endeavor of vial adapter (Par. 17-18), teaches an inner tapered surface 15a (Fig. 3 – tapered bore 15a), the inner surface 15a (Fig. 3) creates an interference fit with a needle hub 41 (Fig. 3 – syringe cannula support 41, and Par. 58 – “…syringe cannula assembly 26… is sealably receivable within the tapered bore 15a of body potion. It is important to note that when the syringe cannula support 41 of the cannula assembly 26 is sealably connected to body portion 15 in the manner shown in FIG. 2”) on the syringe 26 (Fig. 3 – syringe cannula assembly 26).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cavity of the combination to be tapered and fit with a needle hub on the syringe as taught by Wyatt, in order to create a sealable connection to the cavity of the vial adapter body (Par. 58 of Wyatt).
Regarding claim 3, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. The combination further discloses wherein the lumen L (see annotated Fig. 2 of Zinger above) and the cavity C (see annotated Fig. 2 of Zinger above) define an inner channel L+C (see annotated Fig. 2 of Zinger above – the lumen L and cavity C form a continuous channel) through which the needle cannula 42 (Fig. 1 of Wyatt) of the syringe 26 (Fig. 1 of Wyatt) passes through (Fig. 1 of Wyatt shows the syringe cannula 42 passes through the channel 18b+15a; Examiner notes that once the combination is made as discussed in claim 1, the needle cannula of Wyatt is incorporated into the device of Zinger, including said needle cannula being placed within the lumen 18b and bore 15a; thus, the limitation is met)
However, the combination does not disclose the needle cannula being non-removably press-fit into a needle hub of the syringe.
Wyatt, in the same field of endeavor of vial adapter (Par. 17-18), teaches the needle cannula 42 (Fig. 3) being non-removably press-fit into a needle hub 41 (Fig. 3 – syringe cannula support 41, and Par. 58 – “…a syringe cannula 42 that is integrally formed with the syringe cannula support 41”) of the syringe 26 (Fig. 3 – syringe cannula assembly 26).
The claimed limitation “being non-removably press-fit into a needle hub” is being treated as a product by process limitation that is an attachment that results from the process of being press-fit. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of being press-fit imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, said limitation is being given very little patentable weight.
Additionally, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle cannula of the combination to be non-removably fit into the needle hub as taught by Wyatt, in order to provide a unitary and integral component which can prevent loose connection or disconnection during usage of the system.
Regarding claim 4, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 3. The combination further discloses wherein the needle cannula 42 (Fig. 1 of Wyatt) does not extend beyond the at least one inlet 41 (Fig. 2 of Zinger) of the stake 38 (Fig. 2 of Zinger).
Examiner notes that once the combination is made as discussed in claim 1, the needle cannula 42 of Wyatt is incorporated into the device of Zinger, and since the needle cannula 42 of Wyatt does not extend beyond the annotated inlet in annotated Fig. 1 of Wyatt above, i.e., the tip of the needle cannula 42 does not extend past the distalmost end of the annotated inlet, the incorporated needle cannula will also not extend beyond the inlet 41 of Zinger in the same manner. Thus, the limitation is met.
Regarding claim 6, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. The combination further discloses wherein the at least one inlet 41 (Fig. 3E of Zinger) of the stake 38 (Fig. 2 of Zinger) extends beyond a sealing member 18 (Fig. 2 of Zinger Fig. 3E of Zinger – rubber stopper 18; Fig. 3E of Zinger shows the inlet 41 pierces through the rubber stopper 18) of the container 11 (Fig. 2 of Zinger) when the fluid container 11 (Fig. 3E of Zinger) is fully depressed against the wall 33 (Fig. 2 of Zinger and Fig. 3E of Zinger – the vial 11 is pressed against the top wall 33).
Regarding claim 7, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. However, the combination does not explicitly disclose wherein a cross-section of the plurality of protruding inner flanges has a substantially rhombic cross section.
While the combination does not disclose a substantially rhombic cross section for the protruding inner flange, the protruding inner flanges 36C of the combination (Fig. 2 of Zinger) can be seen to already have four sides, which meets one of the criteria for the definition of a rhombus according to Merriam-webster – parallelogram with four equal sides and sometimes one with no right angles. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the protruding inner flange of the combination to have substantially rhombus cross-section, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Williams Jr in view of Wyatt as applied to claim 1 above, and further in view of Nord et al. US 2013/0184672 A1 (previously cited, hereinafter Nord).
Regarding claim 9, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. The combination further discloses wherein the prongs 36, 37 (Fig. 2 of Zinger) elastically deform (Fig. 3D-3E of Zinger and Par. 19 of Zinger – members 36, 37 flex outward) when a sealing member 18 (Fig. 2 of Zinger and Fig. 3E of Zinger – rubber stopper 18) of the fluid container 11 (Fig. 2 of Zinger and Fig. 3E of Zinger) is pressed against the stake 38 (Fig. 3D and 3E of Zinger – vial 11 is pressed against to spike 38 to pierce the rubber stopper 18), the prongs 36, 37 (Fig. 2 of Zinger and Fig. 3E of Zinger) locking the fluid container 11 (Fig. 3E of Zinger) when the fluid container 11 (Fig. 3E of Zinger) is fully depressed against the wall 33 (Fig. 2 and Fig. 3E of Zinger – vial 11 rests against the top wall 33 in a locking position, and Par. 19 of Zinger – “Continued depression of the liquid drug delivery device 10 towards the vial 11 causes the vial guidance flex members 37 to slide over the band's peripheral surface 19 and the vial retention flex members 36 to snap fit over the vial opening 16”).
However, the combination does not explicitly disclose the prongs permanently locking the fluid container.
Nord, in the same field of endeavor of medical device connector (Title), teaches the prongs 50 (Fig. 2b – grip members 50) permanently locking the fluid container 2 (Fig. 1 – vial 2, and Abstract – “A plurality of grip members (50), each grip member (50)… adapted to… permanently lock the medical device connector (1) to the vial (2)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of the combination such that they provide a permanent locking to the fluid container as taught by Nord, in order to minimize leakage and minimize the risk of leakage (Par. 2 of Nord). This prevents exposure to hazardous medicaments that nursing personnel can experience, which can cause illness (Par. 2 of Nord).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Williams Jr in view of Wyatt as applied to claim 1 above, and further in view of Whelan US 2022/0274115 A1 (previously cited, hereinafter Whelan).
Regarding claim 10, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. However, the combination does not disclose further comprising a removable seal disposed over the prongs.
Whelan, in the same field of endeavor of connector with a spike (Abstract and Figs 5-6), teaches further comprising a removable seal 90 (Fig. 9-10 – closure 90, and Par. 84 – “…the closure 90 being removed before use”) disposed over the prongs (Fig. 9-10 – subculture unit 10, left and right).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prongs of the combination to further include a removable seal as taught by Whelan, in order to maintain sterility before use (Par. 84 of Whelan).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Williams Jr in view of Wyatt as applied to claim 1 above, and further in view of Peterson et al. US 5,893,397 A (previously cited, hereinafter Peterson).
Regarding claim 11, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 1. The combination further discloses wherein the connecting member 32 (Fig. 1-2 of Zinger) of the elongated body E (see annotated Fig. 2 of Zinger above) comprises a male thread (Fig. 1 of Zinger; Examiner notes that while Zinger calls connecting member 32 as female, the threads shown in Fig. 1 is external, thus making it male).
However, the combination does not disclose the syringe connecting member comprises a female thread.
Peterson, in the same field of endeavor of medication vial and liquid transfer apparatus (Title), teaches the syringe connecting member 22a (Fig. 1 – syringe body 22a) comprises a female thread 22b (Fig. 1 – communication end 22b; threads 22b being internal, thus is female).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted syringe connecting member’s generic connection means of the combination that provides attachment to the connecting member of the vial adapter, for the female threads as taught by Peterson, since these mechanisms perform the same function of providing coupling between the vial adapter and the syringe. Simply substituting one resilient return means for another would yield the predicable result of allowing an articulated device to return to its initial un-stressed orientation. See MPEP 2143.
Regarding claim 12, Zinger in view of Williams Jr in view of Wyatt suggests the invention of claim 11. The combination further discloses wherein the connecting member 32 (Fig. 1-2 of Zinger) of the elongated body E (see annotated Fig. 2 of Zinger above) and the syringe connecting member 22a (Fig. 1 of Peterson) comprise luer fittings (Par. 17 of Zinger – “…Luer connector 32”, and Col. 4, line 1-5 of Peterson – “Syringe 22… a body 22a having a communication end 22b which is, in the specific style of syringe illustrated, threaded for a so-called (and well-known) Luer-type screw connection…”).
Examiner notes that once the modification is made as discussed in claim 11, the syringe connecting member of Peterson, which is a Luer-type connector, will be incorporated into the device of the combination. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ivosecvic et al. US 2020/0093694 A1 teaches system for closed transfer of fluids (Fig. 7B).Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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