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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/24/2024 was filed before the mailing date of the First Office Action on the Merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maas (U.S. Pre Grant Pub. No. 2020/0330687 A1).
Regarding claim 1, Maas teaches A vial adaptor configured to facilitate transfer of fluid from a vial to a receiving device (see Abstract), the vial adaptor comprising:
a cap (see plunger body 2 in Figs. 1-3 and para. [0014]) comprising a proximal opening (as at numeral 24 in Fig. 1), a distal opening (as at numeral 5 in Fig. 1), at least one detent (see para. [0033]), and a threaded portion (see external thread 11 in para. [0031]) configured to removably couple with a corresponding threaded portion formed on an opening of a vial (para. [0031] teaches the external thread 11 on plunger body 2 engages with internal protrusion 13 on outer tubular casing 8, which is considered to be a vial); and
a piston (see piston 6 in Figs. 1-3 and para. [0017]) comprising a distal end (see insertion end 10 in para. [0017] and Fig. 1), a proximal end (see ejection end 12 in para. [0017] and Fig. 1), a channel (see lumen 14 in para. [0017] and Fig. 1), and a body extending between the distal end and the proximal end (see at least Fig. 1) and comprising a head (as at numeral 18 in Fig. 1), the piston configured to abut an inner surface of the vial (as shown in Fig. 1, the piston 6 is located within tubular casing 8; as broadly recited, the piston 6 abuts the tubular casing such as at numeral 8a in Fig. 1), the channel extending between the distal end and the proximal end of the piston (see Fig. 1) and configured to allow flow of fluid through the piston between the distal end and the proximal end (see para. [0017]), the body comprising at least one groove configured to contact the at least one detent (para. [0033] teaches mechanical detents that provide a tactile feedback for a predetermined amount of fluid ejected from the device 1; additionally, the combination of the plunger body 2 and the syringe body 4 are provided with the mechanical detents; therefore, the piston body 6, which is included within the syringe body 4 has grooves, such as at sealing member 24 which contacts the at least one detent), the at least one groove configured to cause the piston to translate in a first direction relative to the cap when the piston is rotated relative to the cap (as broadly recited, when the syringe body 4, which contains the piston body 6, is rotated about plunger body 2, the piston will translate in a first direction away or towards the ampoule 3), translation of the piston in the first direction configured to cause a positive pressure change in the vial and withdrawal of fluid stored in the vial through the channel of the piston (as described in para. [0018-0019] piston member 6 is forced, via distal translation, through a wall part 7 of the ampoule 3 and substantially forces or urges the sample fluid contained in the ampoule 3 through the lumen 14 to the ejection end 12 as it moves deeper into the interior of the ampoule 3 via positive displacement action; see also Figs. 1-3).
Regarding claim 2, Maas teaches the invention as discussed above in claim 1. Additionally, Maas teaches wherein the first direction is a direction towards the vial (see for example arrow D in Fig. 1).
Regarding claim 3, Maas teaches the invention as discussed above in claim 1. Additionally, Maas teaches wherein the at least one groove comprises one or more locks configured to secure the piston in place relative to the cap (as broadly recited, the grooves are considered to be internal protrusion 13 of the outer tubular casing 8; of which the piston 6 is a part of; as shown in Fig. 1, protrusion 13 has a number of teeth that can be considered as locks).
Regarding claim 4, Maas teaches the invention as discussed above in claim 3. Additionally, Maas teaches wherein the one or more locks comprise a first lock (as broadly recited, see the first set of teeth of internal protrusion 13 in Fig. 1), the first lock configured to lock the piston at a first position relative to the cap (as broadly recited, the first set of teeth of internal protrusion 13 cause the piston to move a certain amount relative to the plunger body 2) and a second lock (as broadly recited, see the second set of teeth of internal protrusion 13 in Fig. 1), the second lock configured to lock the piston at a second position relative to the cap (as broadly recited, the second set of teeth of internal protrusion 13 cause the piston to move a certain amount relative to the plunger body 2).
Regarding claim 5, Maas teaches the invention as discussed above in claim 3. Additionally, Maas teaches wherein at least one of the one or more locks comprises a ridge disposed within the at least one groove (see for example the area between the teeth of internal protrusion 13).
Regarding claim 6, Maas teaches the invention as discussed above in claim 1. Additionally, Maas teaches wherein the piston further comprises a seal configured to abut an interior surface of the vial (see for example filter member 34 in Fig. 1 and para. [0048]).
Regarding claim 7, Maas teaches the invention as discussed above in claim 1. Additionally, Maas teaches wherein the proximal end of the piston is configured to removably couple with a receiving device (see for example container part 16 in Fig. 1 and para. [0019] which is connectable to the ejection end 12 of the piston member 6).
Regarding claim 8, Maas teaches the invention as discussed above in claim 1. Additionally, Maas teaches wherein the piston comprises a stopper (see for example attachment portion 18 in Fig. 1 and para. [0019]) extending radially and circumferentially outwards from the body of the piston (see Fig. 1 showing the attachment portion 18 extending radially and circumferentially outwards from the body of the piston 6), wherein the stopper is configured to abut the cap when the piston is in a distal-most position with respect to the cap (as shown in Fig. 3, the attachment portion 18 abuts the plunger body 2 when the piston 6 is inserted all the way through the ampoule 3).
Regarding claim 9, Maas teaches: A vial adaptor (see Abstract) comprising:
a cap (see plunger body 2 in Figs. 1-3 and para. [0014]) configured to removably couple with an opening of a vial (para. [0031] teaches the external thread 11 on plunger body 2 engages with internal protrusion 13 on outer tubular casing 8, which is considered to be a vial); and
a piston (see piston 6 in Figs. 1-3 and para. [0017]) comprising a distal end (see insertion end 10 in para. [0017] and Fig. 1), a proximal end (see ejection end 12 in para. [0017] and Fig. 1), a body extending between the distal end and the proximal end (see at least Fig. 1), and a channel (see lumen 14 in para. [0017] and Fig. 1), the channel configured to allow flow of fluid through the piston (see para. [0017]) between a distal aperture formed on the distal end of the piston (as at numeral 10 in Fig. 1) and a proximal aperture formed on the proximal end of the piston (as at numeral 18 in Fig. 1), the piston configured rotate and thereby translate distally through the cap and towards the vial (as broadly recited, when the syringe body 4, which contains the piston body 6, is rotated about plunger body 2, the piston will translate in a first direction away or towards the ampoule 3);
wherein a distal translation of the piston is configured to cause a positive pressure change in the vial and withdrawal of fluid stored in the vial through the channel of the piston (as described in para. [0018-0019] piston member 6 is forced, via distal translation, through a wall part 7 of the ampoule 3 and substantially forces or urges the sample fluid contained in the ampoule 3 through the lumen 14 to the ejection end 12 as it moves deeper into the interior of the ampoule 3 via positive displacement action; see also Figs. 1-3).
Regarding claim 10, Maas teaches the invention as discussed above in claim 9. Additionally, Maas teaches wherein the cap comprises a detent (see para. [0033]), wherein the piston comprises a groove (para. [0033] teaches mechanical detents that provide a tactile feedback for a predetermined amount of fluid ejected from the device 1; additionally, the combination of the plunger body 2 and the syringe body 4 are provided with the mechanical detents; therefore, the piston body 6, which is included within the syringe body 4 has grooves, such as at sealing member 24 which contacts the at least one detent), and wherein the detent is configured to engage the groove to allow rotation of the piston relative to the cap to cause distal translation of the piston through the cap towards the vial (as broadly recited, when the syringe body 4, which contains the piston body 6, is rotated about plunger body 2, the piston will translate in a first direction away or towards the ampoule 3).
Regarding claim 11, Maas teaches the invention as discussed above in claim 10. Additionally, Maas teaches wherein the groove comprises a first lock (as broadly recited, see the first set of teeth of internal protrusion 13 in Fig. 1), the first lock configured to prevent motion of the piston relative to the cap absent a threshold force imparted by a user (as broadly recited, the first set of teeth of internal protrusion 13 cause the piston to move a certain amount relative to the plunger body 2 when a user applies a certain amount of rotational force to the plunger body 2 and the syringe body 4).
Regarding claim 12, Maas teaches the invention as discussed above in claim 11. Additionally, Maas teaches wherein the groove comprises a second lock (as broadly recited, see the second set of teeth of internal protrusion 13 in Fig. 1), wherein the first lock is configured to secure the piston in a pre-actuation position absent a threshold force imparted by the user (as broadly recited, the first set of teeth secure the piston body 6 at a first position, which can be considered a pre-actuation position), and wherein the second lock is configured to secure the piston in a post-actuation position and configured to provide a user with tactile feedback that actuation of the piston is complete (as broadly recited, the second set of teeth of internal protrusion 13 cause the piston to move a certain amount relative to the plunger body 2; as taught in para. [0033] the mechanical detents provide a tactile feedback that a predetermined amount of fluid is ejected from the device 1).
Regarding claim 13, Maas teaches the invention as discussed above in claim 9. Additionally, Maas teaches wherein the piston comprises a stopper (see for example attachment portion 18 in Fig. 1 and para. [0019]) extending radially and circumferentially outwards from the body of the piston (see Fig. 1 showing the attachment portion 18 extending radially and circumferentially outwards from the body of the piston 6), wherein the stopper is configured to abut the cap when the piston is in a post-actuation position with respect to the cap (as shown in Fig. 3, the attachment portion 18 abuts the plunger body 2 when the piston 6 is inserted all the way through the ampoule 3).
Regarding claim 14, Maas teaches the invention as discussed above in claim 9. Additionally, Maas teaches further comprising a seal (see for example filter member 34 in Fig. 1 and para. [0048]), wherein the seal is configured to wrap about at least a portion of the distal end of the body of the piston (see Fig. 1).
Regarding claim 15, Maas teaches the invention as discussed above in claim 14. Additionally, Maas teaches wherein the seal is configured to abut an inner surface of the vial (see Fig. 1; as broadly recited the abutment does not have to be a direct contact between the filter member 34 and the inner surface of ampoule 3) to create a watertight barrier between the seal and the inner surface of the vial (para. [0048] teaches that the filter member 34 blocks wall fragments and debris from being ejected; therefore, it creates a watertight barrier).
Regarding claim 16, Maas teaches A method of withdrawing fluid stored in a vial via a vial adaptor (see Abstract), the method comprising:
coupling (see Figs. 1-3) a distal opening (as at numeral 5 in Fig. 1) of a cap (see plunger body 2 in Figs. 1-3 and para. [0014]) of a vial adaptor to an opening of a vial (see plunger body 2), the cap comprising a proximal opening (as at numeral 24 in Fig. 1) opposite of the distal opening (see Fig. 1);
coupling (see at least Fig. 1) a proximal end (see ejection end 12 in para. [0017] and Fig. 1) of a piston (see piston 6 in Figs. 1-3 and para. [0017]) of the vial adaptor to an opening of a receiving device (see for example container part 16 in Fig. 1 and para. [0019] which is connectable to the ejection end 12 of the piston member 6);
rotating the piston relative to the cap and the vial (as broadly recited, when the syringe body 4, which contains the piston body 6, is rotated about plunger body 2, the piston will translate in a first direction away or towards the ampoule 3), thereby causing distal translation of the piston towards the vial and through the proximal opening and the distal opening of the cap (see for example arrow D in Fig. 1), the piston configured to abut an inner surface of the vial (as shown in Fig. 1, the piston 6 is located within tubular casing 8; as broadly recited, the piston 6 abuts the tubular casing such as at numeral 8a in Fig. 1) to create a watertight barrier between the piston and the inner surface of the vial (para. [0048] teaches that the filter member 34 blocks wall fragments and debris from being ejected; therefore, it creates a watertight barrier), the distal translation of the piston towards the vial thereby generating a positive pressure change in the vial causing a flow of fluid stored in the vial through a channel (see lumen 14 in para. [0017] and Fig. 1) of the piston (as described in para. [0018-0019] piston member 6 is forced, via distal translation, through a wall part 7 of the ampoule 3 and substantially forces or urges the sample fluid contained in the ampoule 3 through the lumen 14 to the ejection end 12 as it moves deeper into the interior of the ampoule 3 via positive displacement action; see also Figs. 1-3).
Regarding claim 17, Maas teaches the method as discussed above in claim 16. Additionally, Maas teaches wherein the piston comprises a seal (see for example filter member 34 in Fig. 1 and para. [0048]), the seal covering at least a portion of a distal end of the piston (see at least Figs. 1-2).
Regarding claim 18, Maas teaches the method as discussed above in claim 16. Additionally, Maas teaches wherein the cap comprises a detent (see para. [0033]) and the piston comprises a groove configured to engage the detent (para. [0033] teaches mechanical detents that provide a tactile feedback for a predetermined amount of fluid ejected from the device 1; additionally, the combination of the plunger body 2 and the syringe body 4 are provided with the mechanical detents; therefore, the piston body 6, which is included within the syringe body 4 has grooves, such as at sealing member 24 which contacts the at least one detent), and wherein rotation of the piston causes the detent to travel along a path defined by the groove (as broadly recited, when the syringe body 4, which contains the piston body 6, is rotated about plunger body 2, the piston will translate in a first direction away or towards the ampoule 3), thereby causing distal translation of the piston relative to the cap (see arrow D in Fig. 1).
Regarding claim 19, Maas teaches the method as discussed above in claim 18. Additionally, Maas teaches comprising rotating the piston past a pre-actuation position (as broadly recited, see the first set of teeth of internal protrusion 13 in Fig. 1; the first set of teeth secure the piston body 6 at a first position, which can be considered a pre-actuation position), wherein, at the pre-actuation position, the detent is engaged by a first lock (as broadly recited, the first set of teeth of internal protrusion 13 in Fig. 1 are considered to be the first lock, which engage with corresponding first set of teeth of external thread 11).
Regarding claim 20, Maas teaches the method as discussed above in claim 18. Additionally, Maas teaches comprising rotating the piston to a post-actuation position (as broadly recited, see the second set of teeth of internal protrusion 13 in Fig. 1; the second set of teeth of internal protrusion 13 cause the piston to move a certain amount relative to the plunger body 2; as taught in para. [0033] the mechanical detents provide a tactile feedback that a predetermined amount of fluid is ejected from the device 1), wherein, at the post-actuation position, the detent is engaged by a second lock (as broadly recited, the second set of teeth of internal protrusion 13 in Fig. 1 are considered to be the second lock, which engage with corresponding second set of teeth of external thread 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meyer (U.S. Patent No. 4,809,711 A) – Prefilled Ampoule-Syringe
Stevens (U.S. Patent No. 5,735,825 A) – Syringe Plunger Tip
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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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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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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