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 .
Response to Amendment
This office action is responsive to the amendment filed on 6/22/2026. As directed by the amendment: claims 1, 9, and 16 have been amended, claim 15 has been cancelled, and claims 24-25 have been added. Claims 1-8, 16-17, and 19 are previously withdrawn from consideration. Thus, claims 1-14, 17, 19, and 23-25 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to the independent claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
Claim 9-14 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014177347 A1, henceforth written as Pipelka, in view of US 20160367439 A1, henceforth written as Davis, in view of WO 2014077877 A1, henceforth written as White, and in view of US 20160067406 A1, henceforth written as Goodman.
Regarding Claim 9,
Pipelka discloses:
A system for preparing a sealant delivery apparatus for use in a lung access procedure, comprising:
(system including transfer device 10 and containers 40 50; fig 1-12)
a [first container], a first component chamber having a first component port -- the first component chamber initially containing a first powder or solution component of --;
(container 50 containing a liquid or powder for mixing; fig 1)
a [second container], a first component reservoir having a first transfer port, --,
(container 40 containing a liquid or powder for mixing; fig 1)
a coupling mechanism having a first coupling end and a second coupling end, the first coupling end configured to releasably connect to the [first container], and the second coupling end configured to releasably connect to the [second container],,
(transfer device 10 having opposing ends with connection adapters 30 for connecting to containers 40 50; fig 1)
the coupling mechanism having a first passage --, wherein the first passage is configured to facilitate fluid communication between the first transfer port -- and the first component port --,
(passage spanning channel 13 and bore 24; fig 12)
--and a plurality of connectors, each connector of the plurality of connectors being releasably connectable to the [first container and second container],
(connectors 30; fig 1-12)
--wherein [first container and second container]are configured to alternatingly transfer any contents [between the first container and the second container], respectively,
(contents of containers 40 50 are mixed together due to pressure differentials between the containers)
Pipelka discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the coupling mechanism including a plurality of snap latches;
and a plurality of connectors, each connector of the plurality of connectors including a snap catch configured to releasably engage one of the snap latches of the plurality of snap latches of the coupling mechanism:
However Davis teaches that conical fittings may be equivalently mated by either opposingly mated threads rotating relative to eachother, see fig 31-33, by a snap catch/latch mechanism, see fig 34-42, or advantageously by a mechanism capable of either rotating or axial motion to couple/disconnect, see fig 13-15.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the external and internal threads disclosed by Pipelka for the dual mechanism snap-threads taught by Davis, such that Davis’ coupling mechanism and connectors may couple/decouple via either purely axial or relative-rotary motion, in order to advantageously arrive at an invention which improves the usability of the coupling mechanism and connectors by providing a multitude of manners to couple/decouple them, see paragraph 72-73 of Davis and see MPEP 2144.06(ii).
Pipelka in view of Davis discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
Syringes exchanging media therebetween via action of their plungers
However Pipelka teaches page 4 paragraph 5 to page 5 paragraph 3 and page 11 paragraph 4 to page 12 paragraph 1 that its containers for mixing therebetween may optionally be replaced with syringes as equivalent means of holding ingredients and mixed solutions of ingredients.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the positively/negatively pressurized containers containing an ingredient for mixing of Pipelka with the pressurizable/depressurizable syringes containing an ingredient for mixing of Pipelka, as they are art recognized equivalents known for the same purpose of containing ingredients of solutions before and after mixing, see MPEP 2144.06(ii).
Pipelka in view of Davis discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a first pair of syringes that includes --, a first component chamber having a first component port, and a second component chamber having a second component port, and wherein --includes a first piston and a second piston, the first piston being positioned in the first component chamber and the second piston being positioned in the second component chamber,
a second pair of syringes that includes --, a first component reservoir having a first transfer port, and a second component reservoir having a second transfer port, and -- a third piston and a fourth piston, the third piston being positioned in the first component reservoir and the fourth piston being positioned in the second component reservoir,
a coupling mechanism having a first coupling end and a second coupling end, the first coupling end configured to releasably connect to the first pair of syringes and the second coupling end configured to releasably connect to the second pair of syringes,
the coupling mechanism having a first passage and a second passage, wherein the first passage is configured to facilitate fluid communication between the first transfer port of the second pair of syringes and the first component port of the first pair of syringes,
and wherein the second passage is configured to facilitate fluid communication between the second transfer port of the second pair of syringes and the second component port of the first pair of syringes,
Notably, MPEP 2144.04(VI)(B) provides that a modification of the prior art amounting to a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Accordingly, duplicating syringes and the fluid mixing passages & connectors which connect said syringes of the modified invention of Pipelka in view of Davis such that there are a pair of syringes on either side of a coupling mechanism having multiple passages fluidically connected to multiple connectors which respectively mate with a syringe of a pair of syringes would similarly lack patentable significance as a new and unexpected result is not produced by such a modification.
Further, notably White demonstrates that such a configuration of a pair of syringes 52 engaging with a coupling mechanism 56 to mix solutions with another pair of syringes 54, see fig 1-8, is well known and desirable for simultaneously mixing multiple solutions comprising multiple ingredients.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the syringes, fluid mixing pathways, and syringe-to-coupling-mechanism connecting means disclosed by the modified invention of Pipelka in view of Davis as a matter of obvious design choice which would lack patentable significance and within the routine skill of a person of ordinary skill in the art, see White’s demonstration, to arrive at an invention which may simultaneously mix multiple syringe contents at same time, see MPEP 2144.04(vi)(b).
Pipelka in view of Davis discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a first pair of syringes, that includes a first actuator, and wherein the first actuator includes a first piston and a second piston
a second pair of syringes that includes a second actuator and wherein the second actuator includes a third piston and a fourth piston,
wherein the first pair of syringes and the second pair of syringes are configured to alternatingly transfer any contents of the first component reservoir and the second component reservoir to the first component chamber and the second component chamber, respectively, and to transfer any contents of the first component chamber and the second component chamber to the first component reservoir and the second component reservoir, respectively, by alternatingly depressing the second actuator and the first actuator.
However White teaches that a pair of syringes 52 54 which receive individual stoppers within their chambers 58 60 70 72 have plungers 66 78 with integrally connected heads, therein actuators where a user depressing/pulling the actuator results in a transfer of contents to/from either pair of syringes.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the syringe actuator teachings of White to the pair of syringe of the modified invention, such that Pipelka’s syringe’s plungers are integrally connected at one end as demonstrated by White’s plungers, in order to advantageously arrive at an invention which may transfer contents to/from a pair of syringes in a single actuation driving the plungers within syringes.
Pipelka in view of Davis and White discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the first component chamber initially containing a first powder or solution component of a first sealant component of a multi-component sealant
the second component chamber initially containing a second powder or solution component of the second sealant component of the multi-component sealant
the first component reservoir initially containing a first fluid component of the first sealant component of the multi-component sealant, and the second component reservoir initially containing a second fluid component of the second sealant component of the multi-component sealant
However Pipelka teaches that either container may contain a liquid or powder solution which when mixed with another ingredient produces a desirable medical solution, page 1 paragraph 3.
Further, White teaches that its ingredients may be mixed together to form a sealant for closing a hole in some portion of a patient’s anatomy, see paragraph 30-33.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the mixing ingredients disclosed by Pipelka for the sealant components taught by White, such that the claimed powder/solution ingredients are provided in their respective syringe chamber/reservoir as claimed, in order to advantageously arrive at an invention which can hold and mix ingredients desirable for use in a medical procedure involving sealing some portion of a patient’s anatomy, see page 1 paragraph 3 of Pipelka and paragraph 30-33 of White.
Pipelka in view of Davis and White discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on an applicator for mixed solution within the containers particularly comprising:
an injection needle assembly having a hub and an elongate hollow stylet that extends distally from the hub, wherein: the hub is configured for removable connection to the first pair of syringes and to the coupling mechanism, the elongate hollow stylet is configured to facilitate fluid communication with the first component port and the second component port of the first pair of syringes to receive the multi-component sealant; and
However Goodman teaches a solution applicator:
an injection needle assembly having a hub and an elongate hollow stylet that extends distally from the hub,
(applicator component 100 having a housing 160 and a delivery tube 100; fig 2)
wherein: the hub is configured for removable connection to the first pair of syringes and to the coupling mechanism,
(housing 170 of component 100 connects to a pair of syringes, at fluid housing component 300, via an intermediary coupling mechanism, bridge 350; fig 1+5-6+8)
the elongate hollow stylet is configured to facilitate fluid communication with the first component port and the second component port of the first pair of syringes to receive the multi-component sealant; and
(paragraph 56; tube 100 is in fluid communication with the contents of barrels 310 310b via lumens 120 130; fig 1+3-4+10)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the applicator Goodman for applying solution contained within a pair of syringes to the modified invention, such that Goodman’s housing is configured to mate with the modified invention’s coupling mechanism of Pipelka in view of Davis and White, in order to advantageously arrive at a system of the invention which is enabled to receive, mix, and dispense the sealant contents of a pair of syringes, see paragraph 56 of Goodman.
Regarding claim 10, Pipelka in view of Davis, White, and Goodman teaches:
The system according to claim 9, wherein the first actuator of the first pair of syringes is configured to simultaneously move the first piston and the second piston, and wherein the second actuator of the second pair of syringes is configured to simultaneously move the third piston and the fourth piston.
White: (integral formation of plunger 66 78 are configured to simutanesouly move the individual stoppers within the respective first and second pair of syringes; fig 4-5)
Regarding claim 11, Pipelka in view of Davis, White, and Goodman teaches:
The system according to claim 9, wherein the second pair of syringes is configured such that a first depression of the second actuator simultaneously transfers the first fluid component of the first sealant component into the first component chamber carrying the first powder or solution component of the first sealant component and transfers the second fluid component of the second sealant component into the second component chamber carrying the second powder or solution component of the second sealant component.
White: (integral formation of plunger 66 78 are configured to simutanesouly move the individual stoppers within the respective first and second pair of syringes; fig 4-5)
Examiner notes in light of the modification made in claim 9 above, depression of the claimed second actuator results in the claimed transferring of sealant components between syringes chamber/reservoirs.
Regarding claim 12, Pipelka in view of Davis, White, and Goodman discloses:
The system according to claim 9, wherein the second actuator and the first actuator are alternatingly depressed until a respective dry component of the first sealant component or the second sealant component is fully hydrated by a respective fluid component of the first sealant component or the second sealant component .
Examiner notes in light of the modification made in claim 9 above, depression of the claimed actuators results in the claimed transferring of sealant components between syringes chamber/reservoirs until adequate mixing occurs.
Regarding claim 13, Pipelka in view of Davis, White, and Goodman discloses:
The system according to claim 9, wherein: the first pair of syringes and the second pair of syringes are configured to hydrate the first powder or solution component with the first fluid component to form the first sealant component of the multi-component sealant, wherein when fully hydrated, the first sealant component of the multi-component sealant resides in the first component chamber of the first pair of syringes; and the first pair of syringes and the second pair of syringes are configured to hydrate the second powder or solution component with the second fluid component to form the second sealant component of the multi-component sealant, wherein when fully hydrated, the second sealant component of the multi-component sealant resides in the second component chamber of the first pair of syringes.
Examiner notes in light of the modification made in claim 9 above, depression of the claimed actuators results in the claimed transferring of sealant components between syringes chamber/reservoirs until adequate mixing occurs.
Regarding claim 14, Pipelka in view of Davis, White, and Goodman teaches:
The system according to claim 9, wherein the plurality of snap latches includes a first snap latch and a second snap latch at a first coupled end of the coupling mechanism, and the plurality of snap latches includes a third snap latch and a fourth snap latch at a second coupled end of the coupling mechanism, and wherein the plurality of connectors includes a first connector with a first snap catch associated with the first component chamber of the first pair of syringes, the first snap catch configured to releasably engage the first snap latch of the coupling mechanism; the plurality of connectors includes a second connector with a second snap catch associated with the second component chamber of the first pair of syringes, the second snap catch configured to releasably engage the second snap latch of the coupling mechanism; the plurality of connectors includes a third connector with a third snap catch associated with the first component reservoir of the second pair of syringes, the third snap catch configured to releasably engage the third snap latch of the coupling mechanism; and the plurality of connectors includes a fourth connector with a fourth snap catch associated with the second component reservoir of the second pair of syringes, the fourth snap catch configured to releasably engage the fourth snap latch of the coupling mechanism.
Examiner notes that in light of the modification made in claim 9 above, the claimed coupling mechanism and claimed appropriate number of connectors of Pipelka feature the claimed snap catches and snap latches of Davis in the claimed configuration for coupling/decoupling thebetween. Further Examiner notes that each connector 30 of Pipelka mates with its corresponding container/syringe via snap closure pegs on the connector 30 engaging with snap closure mechanisms on the container/syringe.
Regarding claim 23, Pipelka in view of Davis, White, and Goodman discloses:
The system according to claim 9, wherein each connector of the plurality of connectors is configured to form a threaded or a snap-fit connection with the first pair of syringes and the second pair of syringes.
Pipelka: (page 10 paragraph 3 to page 11 paragraph 1; connector 30 forms a snap fit engagement with the container/syringe connected to it; fig 1-12)
Regarding claim 24, Pipelka in view of Davis, White, and Goodman discloses:
The system according to claim 9, wherein the plurality of snap latches of the coupling mechanism are engageable with the injection needle assembly.
Examiner notes that in light of the modification made in claim 9 above, the injection needle assembly of Goodman, component 100, is render coupleable with the modified invention of coupling mechanism of Pipelka in view of Davis, such that Goodman’s component 100 is engageable with the snap latches of Davis disposed on Pipelka’s coupling mechanism.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Pipelka in view of Davis, White, and Goodman as applied to claim 9 above, and further in view of US 10596067 B2, henceforth written as Osbourne.
Regarding Claim 25,
Pipelka in view of Davis, White, and Goodman discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The system according to claim 9, wherein the elongate hollow stylet has a side wall that surrounds a lumen, the elongate hollow stylet has a proximal portion and a distal portion, --
Goodman: (fig 2; tube 110 has first end 114 and second end 112)
the [outlet ports are] configured for fluid communication with the first component port and the second component port of the first pair of syringes,
Goodman: (paragraph 56; fluid from pair of syringe may be either mixed at the injection site, or mixed within the delivery tube)
However, Pipelka in view of Davis, White, and Goodman is silent regarding:
wherein the elongate hollow stylet has a side wall that surrounds a lumen,
the elongate hollow stylet has a proximal portion and a distal portion,
the distal portion has a closed distal end and a plurality of side ports proximal to the closed distal end,
the plurality of side ports radially extend from the lumen and through the side wall of the elongate hollow stylet in the distal portion,
and the plurality of side ports are configured for fluid communication with the first component port and the second component port of the first pair of syringes
However, Osbourne teaches a multi-lumen mixing device where mixing occurs within a tube prior to delivery to an injection site comprising:
the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end,
(fig 1 and col 4 line 3-17; tip 44 is shown as closed with side ports 146 147 disposed proximally)
the elongate hollow stylet having a side wall that surrounds a lumen,
(wall (not enumerated) of reaction chamber 160
wherein the plurality of side ports radially extend from the lumen and through the side wall of the elongate hollow stylet in the distal portion,
(see fig 1, demonstrating side ports 146 147 extending radially)
the plurality of side ports configured for fluid communication with the first component port and the second component port of the -- device.
(fig 1 demonstrates fluid communication between side ports 146 147 and infusion devices 110 120)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to replace the outlet ports and delivery tube taught by Goodman in the modified invention with the mixing tube having a plurality of side ports as taught by Osbourne in order to arrive at a sealant delivery device which advantageously mixes a sealant within a delivery tube, see paragraph 56 of Goodman, and more evenly distributes sealant around the device as compared to distributing in a singular direction away from the device, see fig 6-8 of Osbourne.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/ Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
