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 1/20/2026. As directed by the amendment: claims 1, 9, 12, 15-16 have been amended, claim 22 has been cancelled. Claims 1-8, 16-17, and 19 are previously withdrawn from consideration. Thus, claims 1-17, 19, and 23 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the independent claims on page 11-15:
Applicant argues that a person of ordinary skill in the art would not be motivated to modify the prior art of White in view of the teachings of Kubo for the reasons detailed in the preceding office action because the prior art of White already provides the advantage gained by the modification of White in view of Kubo.
Examiner notes that in the prior art of White, upon connection of syringe 54 with adapter 56 the syringe 54's needles 80 82 penetrate the seal member 112 of adapter 56 immediately upon the mating of connector 88's lip 89 with connector stops 110, see paragraph 50-51 of White. However, critically in the prior art of Kubo connection device 1 must first be mated to syringe 2 when thread portions 32a have mated with external thread portion 12c and then after arriving in this attached state, being moved to a pre-use state where holding protrusions 43 about vial 3 and the seal penetrating cannulas do not yet penetrate either seal and the connection device 1 cannot yet be removed from syringe 2, and after arriving in this pre-use state where the syringe 2 and vial 3 have been indirectly mated together via connection device 1, the syringe 2 and vial 3 may be pressed closer together to initiate puncturing of the seals and consequently enable fluid conveyance. Kubo's additional steps and an intermediary components relied upon in fluidically mating syringe 2 and vial 3 are desirable and advantageous over the fluid coupling structure of White in that they prevent an error by a user, for instance assuming that contact of one structure with another permits the conveyance of fluid when in fact fluid is not being conveyed, and consequently prevent a user from forgetting to perform an operation of establishing fluid communication until a manual telescoping motion occurs between the intermediary elements to penetrate multiple septums sequentially and permit fluid flow. These additional connection steps require direction action and verification by a user, and thus reduce the risk at any one step of a user making an error assuming the fluid communication has been completed.
Applicant also argues that a person of ordinary skill in the art would not reasonably equate Kubo's vial 3 to the adapter 56 such that it would be obvious to consider them functional equivalents and implement the teachings of Kubo with White.
However, as examiner clearly detailed in the interview dated 1/12/2026, that such fluid connectors address the same problem applicant the same problem applicant is trying to solve of mating together fluid retainers for fluid transference therebetween.
Examiner notes that Kubo's vial 3 retains fluid in its bottle portion 21, as does White's adapter 56 retain fluid in its channels 100 102, and as does applicant's coupling mechanism 122 in its passage 150-1-2.
Applicant also argues that the office action relied upon impermissible hindsight bias because the disclosure of White and Kubo disclose three-piece assemblies comprising a first fluid device, a second fluid device, and a fluid coupling device facilitating transfer of fluid therebetween and as such a connector that is releasably connectable to a syringe and releasable connectable to a fluid coupling device is only gleaned from the present disclosure.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner also notes that applicant is narrowly interpreting the prior art such that intermediary fluid conveying structures, such as White's connectors 68 88, White's needle 88, Kubo's connection portion 12, Kubo's flange portion 21a, are not considered distinct pieces of the assemblies, despite the disclosures themselves referring to them as distinctly named components. Interposing an intermediary fluid conveying structure whether releasable or not-releasable, or making an intermediary fluid conveying structure releasable based on teachings from available prior art is not limited to art where applicant chooses to only delineate a certain number of fluid conveying structures. The following office action is clear in its motivation for the provided combination of the prior art that it does not rely upon impermissible hindsight.
Applicant further argues that the modification of White in view of Kubo would change the principle of operation of White's invention and render it unsatisfactory for its intended purpose.
See examiner's rejection as necessitated by the amendment, below, which demonstrates that the seals maintaining the sterility of White's invention and thus its intended purpose as noted by applicant are note destroyed in the modification of White in view of Kubo.
See examiner's rejection as necessitated by the amendment below, which provides the manner by which the prior art of record is relied upon to disclose/teach the limitations of the amended claims.
Regarding applicant’s argument regarding dependent claims on page 15-16:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Claim Rejections - 35 USC § 103
Claim 9-14 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014077877 A1, henceforth written as White, further in view of US 8900212 B2, henceforth written as Kubo .
Regarding Claim 9,
White discloses:
A system for preparing a sealant delivery apparatus for use in a lung access procedure, comprising:
(sealant mixing assembly 18; fig 1)
a first pair of syringes,
(first syringe pair 52; fig 1)
that includes a first actuator,
(plunger 66; fig 2)
a first component chamber having a first component port,
(first chamber 58 has connector 68; fig 2)
and a second component chamber having a second component port,
(second chamber 60 has connector 68; fig 2)
and wherein the first actuator includes a first piston and a second piston,
(fig 2, shows distinct pistons (not enumerated) extending from plunger 66 for each chamber 58 60)
the first piston being positioned in the first component chamber and the second piston being positioned in the second component chamber,
(fig 2, distinct pistons (not enumerated) of plunger 66 extend into chamber 58 60)
the first component chamber initially containing a first powder or solution component of a first sealant component of a multi-component sealant,
(paragraph 41+55; first sealing component 62; fig 2)
and the second component chamber initially containing a second powder or solution component of the second sealant component of the multi-component sealant;
(paragraph 41+55; second sealing component 64; fig 2)
a second pair of syringes that includes a second actuator,
(second syringe pair 54 with plunger 78; fig 2)
a first component reservoir having a first transfer port,
(third chamber 70 having an outlet, the claimed first transfer port, leading to first needle 80; fig 2)
and a second component reservoir having a second transfer port,
(fourth chamber 72 having an outlet, the claimed first transfer port, leading to second needle 82; fig 2)
and wherein the second actuator includes a third piston and a fourth piston,
(fig 2, shows distinct pistons (not enumerated) extending from plunger 78 for each chamber 70 72)
the third piston being positioned in the first component reservoir and the fourth piston being positioned in the second component reservoir,
(fig 2, distinct pistons (not enumerated) of plunger 66 extend into chamber 70 72)
the first component reservoir initially containing a first fluid component of the first sealant component of the multi-component sealant,
(paragraph 55; third sealant component 74; fig 2)
and the second component reservoir initially containing a second fluid component of the second sealant component of the multi-component sealant;
(paragraph 55; fourth sealant component 76; fig 2)
a coupling mechanism (adaptor 56; fig 2) having a first coupling end (portion of adaptor 56 near seats 104; fig 2) and a second coupling end, (portion of adaptor 56 near connector stops 110; fig 2)
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,
(fig 2-8, show the first syringe pair 52 and second syringe pair 54 removably coupling to adaptor 56)
the coupling mechanism having a first passage (first channel 100; fig 2) and a second passage, (second channel 102; fig 2)
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,
(paragraph 52; first channel 100 links first chamber 58 and third chamber 74; fig 4)
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, --
(paragraph 52; second channel 102 links second chamber 60 and fourth chamber 76; fig 4)
-- and a plurality of connectors, --
(paragraph 41-49; connector 68 rely upon a protrusion mating with a respective connector seat 104 for forming a fluidic connection between the two fluid retaining structures of adapter 56 and syringe pair 52, and similarly connector 88 rely upon lips 89 securing to connector stops 110 for forming a fluidic connection between the two fluid retaining structures of adapter 56 and syringe pair 54; fig 2-8 demonstrate the connection/disconnection of the fluid retaining structures, and threaded structures; paragraph 42+46 particularly note that other types of connectors, such as snap-fit features, latches, clips, brackets, other features formed on interior or exterior surfaces of the fluid retaining structures, may be relied upon to secure a fluidic connection between these two fluid retaining structures)
--and 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,
(paragraph 52 + fig 4-5, show the alternating actuation of syringes 52 54 to form sealant mixtures 116 118)
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.
(paragraph 52 + fig 4-5, demonstrate contents of chambers 58 60 70 72 being transferred therebetween by the alternating depression of plunger 66 78)
However, the device of White remains silent regarding:
the coupling mechanism including a plurality of [snapping latch-catch structure]
each connector of the plurality of connectors being releasably connectable to the first pair of syringes and the second pair of syringes,
and each connector of the plurality of connectors including a [mating snapping latch-catch structure] configured to releasably engage one of the [snapping latch-catch structures] of the plurality of [snapping latch-catch structures] of the coupling mechanism
Notably, Kubo teaches:
a connector being releasably connectable to [a syringe],
(col 5 line 36-col 6 line 15 and col 7 line 50-62; connector 1 can be connected and released, therein releasably connectable, to syringe 2; fig 4a-b+5a-b)
and [the] connector [includes a snap latch] configured to releasably engage a [snap catch of a fluid retaining structure which the syringe is coupled to]
(col 4 line 56- col 5 line 12 and col 6 line 37- col 7 line 8; holding protrusions 45 has a superior angled surface, the claimed snap latch, are biased outward by the outwardly protruding ring member 23 until protrusions 45 passes over ring member 23 and the superior angled surface of protrusions 45 abuts the inferior outwardly protruding surface, the claimed snap catch, of ring member 23; see examiner’s annotation of Kubo’s 4 denoting the superior angled surface of protrusions 45 and inferior outwardly protruding surface of ring member 23)
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Examiner notes that Kubo’s connection device 1 enables selective fluid communication between syringe 2 and vial 3, a fluid conveying mechanism not dissimilar for fluid conveying purposes to a fluid coupling mechanism, by the manner by which it connects to each, and enables translation of a double headed cannula 5 relative to both the syringe 2 and vial 3 such that the cannula 5 enables aseptic/sterile fluid communication by puncturing the lid member 13 and lid member 22, respectively, only when the device 1 is fully connected with both syringe 2 and vial 3; fig 1-5; col 7 line 18-62; the separation prevention means 42, and other aspects of device 1’s design prevent separation of syringe 2 and vial 3 when fluid communication has not been established, therein preventing an error by the user and preventing the user from forgetting to perform the fluid communication operation after the fluid communicating structures had been initially connected.
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 connectors on each syringe and the associated connector mating structure on the coupling mechanism disclosed by White with the connection device and associated connection device mating structures on the fluid conveying structures taught by Kubo, by substituting White’s connectors 68 88 with Kubo’s threaded connection portion 12 having a sealed rubber lid 13 for each syringe in syringe pairs 52 54 as well as substituting White’s connector mating structures 110 104 with Kubo’s ring member 23 and rubber lid member 22 for each side of each channel 100 102 of White such that Kubo’s connection device 1 can be disposed any of chambers 58 60 70 72 and their respective channels 100 102 for fluid conveyance, in order to advantageously arrive at an invention which prevents an error by the user forgetting to perform the fluid communication operation by inhibiting disconnection of the claimed syringe from the claimed coupling mechanism until fluid communication is reached upon the puncturing of the septums covering each fluid conveying structure, see col 7 line 18-62 of Kubo, an invention which comprises a modification of supported and enabled by White’s which details that its connectors may take/include other various forms including threaded mechanisms, needles, and snap fitting mechanisms, see paragraph 42+46 of White, and advantageously permits use of White’s invention with needleless sealed syringes which are conventional in the art and may contain sealant component solutions not available from manufacturers of needled syringes.
Examiner notes concisely for the sake of clarity that the modified invention comprises a sufficient plurality, i.e. four, of Kubo’s connection device 1 which have been demonstrated as being capable of releasably coupling with any and all of the four component chamber/reservoirs of the two pairs of syringes.
However, the device of White in view of Kubo remains silent regarding:
the coupling mechanism including a plurality of snap latches, 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, as examiner noted above in the teachings of Kubo and as implemented in the modification of White in view of Kubo above, Kubo’s connection device 1’s superior angled surface on the biasable protrusion 45 may be considered a snap latch, and White’s adapter 56 has Kubo’s inferior outwardly protruding surface disposed thereon for each outlet/inlet of White’s channels 100 102.
Notably, MPEP 2144.04(VI)(C) details that such a modification of an invention only involving a rearrangement of parts such that shifting the position of those parts would not modify the operation of the device are unpatentable as they pertain to be an obvious matter of design choice. Such a modification merely involving a rearrangement of parts, i.e. swapping the disposition of a snap latch on one element and a snap catch on a member such that snap latch is disposed on the element and snap catch is disposed on the member, would only involve routine skill in the art and a matter of obvious design choice.
Therefore, it would be similarly obvious to rearrange the disposition of Kubo’s snap latch and snap catch, consequently arrive at the claimed invention of a snap catch disposed on a connector and a plurality of snap latches disposed on the coupling mechanism, as such a modification would only involve routine skill in the art, see MPEP 2144.04(VI)(C), and advantageously arrive at an equivalent means of mating two structures together.
Regarding claim 10, the modified invention of White in view of Kubo discloses:
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: (fig 3-5, demonstrate plunger 66 78 both are capable of simultaneously moving their respective distinct pistons (not enumerated))
Regarding claim 11, the modified invention of White in view of Kubo discloses:
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: (fig 4-5, show that depression of plunger 66 78 results in transferring of a component in syringes 52 54 into chambers 58 60 70 72; paragraph 55)
Regarding claim 12, the modified invention of White in view of Kubo 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 .
White: (paragraph 52+55 and fig 3-4, demonstrate alternating between pressing plunger 66 78 to mix powder, a dry component, until it is fully reconstituted, therein hydrated, by solution)
Regarding claim 13, the modified invention of White in view of Kubo 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.
White: (fig 4-5 and paragraph 52, demonstrate that sealing components 62 64 once fully mixed, by exchanging media through syringes 52 54 and channels 100 102, sealant components 74 76 can reside in either syringe 52 or syringe 54)
Regarding Claim 14, the modified device of White in view of Kobu teaches:
The system according to claim 9, wherein the plurality of snap latches includes a first snap latch and a second snap latch at the first coupling end of the coupling mechanism, and the plurality of snap latches includes a third snap latch and a fourth snap latch at the second coupling 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 in light of the combination made in claim 9 above, the present interpretation of White now includes four connection device 1s of Kubo so disposed as to respectively mate each component reservoir/chamber of a pair of syringes with a respective end of the claimed coupling mechanism by means of Kubo’s coupling snap latch-catch structure biasable protrusions 45 and rigid ring members 23, which are disposed in the claimed manner and disclosed in examiners rejection of claim 9 above.
Regarding claim 23, the modified device of White in view of Kobu teaches:
The system according to claim 9, wherein each connector of the plurality of connectors is configured to form a threaded -- connection with the first pair of syringes and the second pair of syringes.
Kobu: (connective device 1 can be considered to form a threaded connection with the pair of syringes by the manner by which its thread portion 32a and 42b engages Kubo’s thread 12c on White’s modified syringe)
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over White in view of Kobu as applied to claim 9 above, and further in view of US 10596067 B2, henceforth written as Osborne.
Regarding Claim 15,
White in view of Kobu 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, further comprising an injection needle assembly having a hub
White: (paragraph 36; sealant delivery device 12 has manifold 20; fig 1)
and an elongate hollow stylet that extends distally from the hub,
White: (paragraph 37; dual lumen tube 22 extends from manifold 20; fig 1)
the hub configured for removable connection to the first pair of syringes,
White: (paragraph 56; fig 1+7-9, demonstrate connection of sealant mixing assembly 18 to sealant delivery device 12 via injection port 24 and syringe 52 by a needle of the invention puncture a seal member of the invention)
Examiner notes that in light of the modification
NEEEDLE
the elongate hollow stylet 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,
White: (fig 9-11, shows dual lumen tube 22 receiving and distributing sealant mixtures 116 118)
the elongate hollow stylet having a proximal portion and a distal portion,
White: (paragraph 38; dual lumen tube 22 has distal ends 32 46 and proximal end 36 48; fig 1)
However, White in view of Kobu is silent regarding:
the hub configured for [fluid] connection to the first pair of syringes, [by piercing seal members of the first pair of syringes with a needle on the hub]
Notably, White does disclose in paragraph 60 that its sealant mixture may be communicated from a pair of syringes by a needle on the syringe which punctures a seal member at the injection port 24.
Examiner further notes in light of the modification of White in view of Kobu in claim 9 above, that White’s syringes ports are sealed with Kobu’s rubber lid member 13.
Notably, MPEP 2144.04(VI)(C) details that such a modification of an invention only involving a rearrangement of parts such that shifting the position of those parts would not modify the operation of the device are unpatentable as they pertain to be an obvious matter of design choice. Such a modification merely involving a rearrangement of parts, i.e. swapping the disposition of a needle on one element and a seal on a member such that seal is disposed on the element and needle is disposed on the member, would only involve routine skill in the art and a matter of obvious design choice.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute White’s seal on its injection port 24 for a needle, consequently arrive at the claimed invention where the claimed hub is configured for fluidically mating with sealed ports of a pair of syringes, as such a modification would only involve routine skill in the art, see MPEP 2144.04(VI)(C), and advantageously arrive at an equivalent means of mating two structures together.
However, White in view of Kobu is silent regarding:
the distal portion having a closed distal end and a plurality of side ports proximal to the closed distal end, the elongate hollow stylet having a side wall that surrounds a lumen, 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, the plurality of side ports configured for fluid communication with the first component port and the second component port of the first pair of syringes.
However, Osborne teaches a multi-lumen mixing device
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 singular side port disclosed by White with the plurality of side ports taught by Keller in order to arrive at a sealant delivery device which advantageously more evenly distributes sealant around the device as compared to distributing in a singular direction away from the device.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783