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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/10/2026.
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, 3-4, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hedges (US 5240047 A) in view of Alsberg et al. (US 20190167526 A1), hereinafter referred to as “Alsberg”.
Regarding Claim 1, Hedges teaches a vial adapter (10, see Figures 1-6) for use with an injector (syringe 30) and a vial (vial 14) containing an injectable fluid (see Col. 1 ln 5-8), the vial including a stopper (needle penetrable cap 34), the injector including a barrel (body of syringe 30) and a needle (needle 10), the vial adapter comprising:
a vial retainer (bottle-holding portion 12), the vial retainer having a generally cylindrical structure having a central opening and being sized to receive at least a portion of the vial (a generally cylindrical shape conforming to the cylindrical shape of a conventional vial or bottle 14, see Figure 3; Col. 2 ln 35-36), the stopper and the stopper retainer,
a spacing disc (front face 22), the spacing disc including a needle insertion port (tunnel member 20), the needle insertion port being sized to permit the passage of the needle and not to allow the passage of the barrel (see Figure 3), and
a spacing arm (guide 18) attached to the vial retainer and the spacing disc (attached to bottle holding portion 12 and front face 22, see Figure 4), the spacing arm being sized to space the spacing disc a predetermined distance from the vial retainer (the syringe is pushed along the guide 18 until it stops and that portion of the syringe which connects to the needle will then abut against the abutment surface 22, see Col. 3 ln 30-33),
wherein when the needle of the injector is inserted through the needle insertion port and into the stopper (the needle 32 can extend through the channel, puncturing the needle penetrable cap 34 on the vial or vial 14 and thus pass into the interior of the bottle 14, see Col. 53-55), a distance that the needle may extend through the stopper is limited by contact of the injector with the spacing disc (the distance between the surface of the syringe guide 18 and the inner peripheral surface of the tunnel member 20 need only be great enough to allow needle 32 clearance and yet provide a stopping surface 22, see Col. 3 ln 52-56).
However, Hedges does not explicitly disclose the vial including a stopper retainer.
Alsberg teaches a vial adaptor (100) for use with an injector (syringe 20) and a vial (10), the vial including a stopper (18) and a stopper retainer (crimp seal 17, see Figure 1).
Hedges and Alsberg are analogous art because both teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the vial of Hedges and further include a stopper retainer, as taught by Alsberg. Alsberg teaches that the crimp seal secures the stopper to vial while providing top access to stopper for needle (see Paragraph [0003]).
Regarding Claim 3, Hedges and Alsberg teach all of the limitations as discussed above in claim 1 and Hedges further teaches wherein the vial retainer (12) includes at least one radial opening through the cylindrical structure (slot 16), the vial retainer being resilient such that at least a portion of the vial, the stopper and the stopper retainer may be advanced in a radial direction through the radial opening into the central opening of the vial retainer (the elasticity of the plastic allows the relatively thin walls of the bottle-holder portion 12 to be slightly expanded when fitted onto the vial 14 so that a good friction-fit is assured, see Col. 2 ln 38-41).
Regarding Claim 4, Hedges and Alsberg teach all of the limitations as discussed above in claim 1 and Hedges further teaches wherein the vial retainer is resilient such that at least a portion of the vial, the stopper and the stopper retainer may be advanced in an axial direction into the central opening of the vial retainer (the elasticity of the plastic allows the relatively thin walls of the bottle-holder portion 12 to be slightly expanded when fitted onto the vial 14 so that a good friction-fit is assured, see Col. 2 ln 38-41).
Regarding Claim 13, Hedges and Alsberg teach all of the limitations as discussed above in claim 1 and Hedges further teaches wherein the vial adapter is reusable on said vial or a different vial (wherein said cavity comprises an elastic material to facilitate removal of said vial from said cavity, see Claim 4).
Claims 2 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hedges and Alsberg, as applied to claim 1 above, and further in view of Mudd (US 20110253251 A1).
Regarding Claim 2, Hedges and Alsberg teach all of the limitations as discussed above in claim 1. However, Hedges and Alsberg do not explicitly disclose wherein an angle at which the needle pierces the stopper is determined by at least one of an angle of at least one surface of the spacing disc to the stopper or a disposition of the spacing disc relative to the vial retainer.
Mudd teaches a vial adapter (needle guide 100, see Figure 1) wherein an angle at which the needle pierces the stopper (303) is determined by at least one of an angle of at least one surface of the spacing disc to the stopper or a disposition of the spacing disc relative to the vial retainer (the angle at which the needle 108 enters the container 103 may be controlled by the angle at which the syringe holder 106 is oriented with respect to the housing 103, see Paragraph [0044]; Figure 3).
Hedges, Alsberg, and Mudd are analogous art because all teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the angle at which the needle pierces the stopper by at least one of an angle of at least one surface of the spacing disc to the stopper, as taught by Mudd. Mudd teaches the angle of the needle piercing the stopper is beneficial so the contents will have pooled, e.g. somewhere along an edge of the base of the container 103 in order to extract the maximum amount of the substance (see Paragraph [0044]).
Regarding Claim 7, Hedges and Alsberg teach all of the limitations as discussed above in claim 1. However, Hedges and Alsberg do not explicitly disclose at least one living hinge disposed between the spacing arm and at least one of the spacing disc and the vial retainer.
Mudd teaches a vial adapter (needle guide 100, see Figure 1) comprising: at least one living hinge disposed between the spacing arm and at least one of the spacing disc and the vial retainer (the syringe holder 106 may be hinged such that it is able to rotate in the same plane in which the housing 102, of an adjustable angle housing 102, is able to pivot, see Paragraph [0046]).
Hedges, Alsberg, and Mudd are analogous art because all teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the spacing arm and the vial retainer of Modified Hedges and further include a living hinge, as taught by Mudd. Mudd teaches that the angle with which the syringe holder 106 is attached to the housing 102 may be adjustable to be chosen to meet the needs of the particular container's 103 configuration (see Paragraph [0045]-[0046]).
Regarding Claim 8, Modified Hedges teaches all of the limitations as discussed above in claim 7 and Mudd further teaches wherein the at least one living hinge provides at most 180 degree of movement between the spacing arm and the at least one of the spacing disc and the vial retainer (an angle guide may also be provided which may allow a user to read off and select a desired angle, see Paragraph [0046]).
Regarding Claim 9, Modified Hedges teaches all of the limitations as discussed above in claim 7 and Mudd further teaches wherein including a second living hinge between the spacing arm and the vial retainer (the syringe holder 106 may be hinged such that it is able to rotate in the same plane in which the housing 102, of an adjustable angle housing 102, is able to pivot, see Paragraph [0046]) allowing the vial adapter to move between a use position (when user is selecting the desired angle, see Paragraph [0047]) and a storage position (any other angle that allows the user to store the vial adaptor).
However, Modified Hedges does not explicitly disclose a first living hinge between the spacing arm and the spacing disc.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the living hinge to have at least two of them since the claims to the said components read on the prior art expect with regard to the additional components would not have modified the operation of the device (moving the vial adaptor from a use position to a storage position). It has also been shown in Mudd that the living hinge in between the spacing arm and the vial retainer can allow the user to position the vial adaptor in a use position. The particular duplication of parts would be obvious matter of design choice to one skilled in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
Regarding Claim 10, Modified Hedges teaches all of the limitations as discussed above in claim 7 and Mudd further teaches at least one engaging structure disposed to maintain the living hinge disposed between the spacing arm and at least one of the spacing disc and the vial retainer in at least one of a use position and a storage position (the syringe holder 106 may include a mechanism to hold it in place once adjusted, e.g. a friction hinge, detents, an adjustable support rod or slider between the syringe holder 106 and housing 102, tensioning hardware, etc., see Paragraph [0046]).
Regarding Claim 11, Hedges and Alsberg teach all of the limitations as discussed above in claim 1. However, Hedges and Alsberg do not explicitly disclose a support structure disposed to support the vial retainer and vial at an angle of less than 90 degrees on a surface.
Hedges teaches a vial adapter (needle guide 100, see Figure 1) comprising: a support structure (base 101) disposed to support the vial retainer (housing102) and vial at an angle of less than 90 degrees on a surface (the base 101 may be designed to rest stably on a flat surface, see Paragraph [0034]; one example needle guides may be constructed with bases 101 and housings 102 which fit a particular container 103 and hold that container 103 at a predetermined angle to vertical i.e. in the range of 15 to 16 degrees, see Paragraph [0038]).
Hedges, Alsberg, and Mudd are analogous art because all teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the vial adaptor of Modified Hedges and further include a support structure disposed to support the vial retainer and vial at an angle of less than 90 degrees on a surface, as taught by Mudd. Mudd teaches it would be beneficial to provide systems and methods which may enable medical practitioners and others to efficiently use injectable material stored in a container. For instance, some example embodiments may provide a needle guide which may be designed to hold a container at an angle which allows material in the container to pool in such a way that it may be maximally extracted. In order to do so, the needle guide may hold the container in a predetermined position relative to the Earth's gravity, i.e. relative to vertical (see Paragraph [0033]).
Regarding Claim 12, Modified Hedges teaches all of the limitations as discussed above in claim 11 and Mudd further teaches wherein the support structure includes a plurality of legs (needle guide 100 may include adjustable feet projecting downward from the base 101, on which the needle holder may rest, see Paragraph [0034]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hedges and Alsberg, as applied to claim 1 above, and further in view of David et al. (WO 2017013645 A1), hereinafter referred to as “David”.
Regarding Claim 5, Hedges and Alsberg teach all of the limitations as discussed above in claim 1. However, Hedges and Alsberg do not explicitly disclose wherein at least one axial retention feature, said axial retention feature being disposed to engage at least one surface of at least one of the vial and the stopper retainer to minimize axial movement of the vial within the vial retainer.
David teaches vial adapter (41, see Figure 4) wherein at least one axial retention feature (slotted section 43), said axial retention feature being disposed to engage at least one surface of at least one of the vial and the stopper retainer to minimize axial movement of the vial within the vial retainer (The slotted section 43 includes four equispaced spacers 44 for abutting against the vial adapter top wall 33, a diametric pair of activation vial retention flex members 46 proximal to the vial adapter top wall 33 and a diametric pair of set-up vial retention flex members 47 distal to the vial adapter top wall 33, see pg. 4 ln 18-22).
Hedges, Alsberg, and David are analogous art because all teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the vial adaptor of Modified Hedges and further include at least one axial retention feature, as taught by David. David teaches the axial retention feature allows for the vial adapters to be implemented in a wide range of liquid drug transfer devices for use with a needleless syringe, an infusion bag, and the like. The liquid drug transfer devices of the present invention can be supplied with a pre-attached injection vial in a set-up position to form a ready-to-use liquid drug reconstitution assemblage (see pg. 2 ln 13-18).
Regarding Claim 6, Modified Hedges teaches all of the limitations as discussed above in claim 5 and David further teaches wherein the at least one axial retention feature (slotted section 43) includes at least one surface that confronts an upper surface of the stopper retainer (flex members 46 proximal to the vial adapter top wall 33, see Figure 6B), and at least one surface that confronts a lower surface of at least one of the stopper retainer and the vial (retention flex members 47 distal to the vial adapter top wall 33, see Figure 6A).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hedges and Alsberg, as applied to claim 1 above, and further in view of Naygauz (US 20200146937 A1).
Regarding Claim 14, Hedges and Alsberg teach all of the limitations as discussed above in claim 1. However, Hedges and Alsberg do not explicitly disclose wherein the vial adapter may be irreversibly attached to a vial.
Naygauz teaches a vial adapter (housing 201, see Figure 9A) wherein the vial adapter may be irreversibly attached to a vial (the attachment between vessel 204 and housing 201 is irreversible and made via teeth 226 that fits and locks into dent 230, see Paragraph [0266]; Figure 9B).
Hedges, Alsberg, and Naygauz are analogous art because all teach a vial adaptor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the vial adaptor of Modified Hedges and further include wherein the vial adapter may be irreversibly attached to a vial, as taught by Naygauz. Naygauz teaches the irreversible attachment to the vial prevents the spillage of a medicinal substance which is particularly dangerous if the medicinal substance is a toxic substance, a teratogenic substance, and the alike (see Paragraph [0009]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carrel et al. (US 9668939 B2) teaches a vial adapter (adaptor 10, see Figure 2A-C) for use with an injector (100) and a vial containing an injectable fluid (vial 1), the vial including a stopper (4) and a stopper retainer (5, see Figure 1C), the injector including a barrel and a needle (see Figure 10B), the vial adapter comprising:
a vial retainer (compressive member 40), the vial retainer having a generally cylindrical structure having a central opening and being sized to receive at least a portion of the vial, the stopper and the stopper retainer (see Figure 2A),
a spacing disc (cap 41), the spacing disc including a needle insertion port (central hole 43), the needle insertion port being sized to permit the passage of the needle and not to allow the passage of the barrel (see Figure 13),
wherein when the needle of the injector is inserted through the needle insertion port and into the stopper (see Figure 13), a distance that the needle may extend through the stopper is limited by contact of the injector with the spacing disc (the distance of the needle is limited by the size of the cap 41). However, Carrel fails to teach a spacing arm attached to the vial retainer and the spacing disc, the spacing arm being sized to space the spacing disc a predetermined distance from the vial retainer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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, 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.
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.
/ERIC RASSAVONG/ (3/13/2026)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781