NON-FINAL 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 Arguments
Claim amendments and Applicant’s arguments filed on 9 October 2025 with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Dodgson have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made over Dodgson in view of McGillicuddy.
Applicant's arguments with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(2) as being anticipated by McGillicuddy have been fully considered but they are not persuasive. Applicant argues that McGillicuddy does not disclose “a connector capable of sealing the end of the conical portion when the connector is joined only to the conical portion and configured to fluidly connect the first fluid transfer container to a second fluid transfer container” (page 6, Remarks). Applicant further asserts that the female swabable Luer disclosed by McGillicuddy does not seal the syringe when the female swabable Luer fitting is attached only to the end of the syringe (page 6, Remarks). The examiner respectfully disagrees. Standard Luer connectors are designed to form a fluid-tight seal at the conical tip of a syringe or container, so sealing is inherent and necessary to their intended purpose. If the Luer connector permits leakage, it would defeat its basic function. Furthermore, McGillicuddy expressly discloses that the female swabable Luer of the first syringe and the male Luer of the second syringe are configured to be joined to each other, therefore establishing direct fluid communication between the two fluid transfer containers as recited in amended claim 1. Therefore, the rejection of claim 1 over McGillicuddy is maintained.
Election/Restrictions
Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 June 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings were received on 24 August 2022. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the transfer assembly" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, it is unclear if “a transfer container” refers to the second transfer container now recited in claim 1, upon which said claim depends, or to a different transfer container. For the purpose of examination, it is assumed that said transfer container refers to the second transfer container in claim 1.
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, 10, and 11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McGillicuddy (U.S. Patent Application No. 2020/0360921).
Regarding claim 1, McGillicuddy discloses a fluid transfer system comprising: a first fluid transfer container (syringe 30; Fig. 3C), the first fluid transfer container including: a tube, the tube including a conical portion at one end, the tube defining an interior space of the tube (Fig. 3C); one or more fluid passages (see annotated Fig. 3C below) configured to allow flow of fluid into or out of the interior space of the tube; a connector (female swabable Luer 48; Fig. 3C) disposed at an end of the conical portion, the connector configured to seal the end of the conical portion when the connector is joined only to the conical portion (para. [0089], Fig. 3C) and configured to fluidly connect the first fluid transfer container to a second fluid transfer container (para. [0017]); and a pressure control mechanism (plunger 40; Fig. 3C) configured to increase or decrease a pressure in the interior space of the tube.
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Regarding claim 10, McGillicuddy discloses a second fluid transfer container (syringe 70; Fig. 3C), the second fluid transfer container including: a second tube, the second tube including a second conical portion at one end, the second tube defining a second internal space (Fig. 3C); and a second connector (male slip fit Luer 86; Fig. 3C), the connector configured to seal the end of the second conical portion when the connector is joined only to the second conical portion, wherein the connector of the first fluid transfer container and the second connector are configured to be joined to one another (para. [0109]; Fig. 3C).
Regarding claim 11, McGillicuddy discloses wherein the connector of the first fluid transfer container (female swabable Luer 48; Fig. 3C) forms a first portion of a swabable valve (para. [109]) and the second connector (male slip fit Luer 86; Fig. 3C) forms a second portion of the swabable valve (Fig. 3C).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dodgson (U.S. Patent Application Pub. No. 2012/0029832) in view of McGillicuddy (U.S. Patent Application No. 2020/0360921).
Regarding claim 1, Dodgson discloses a fluid transfer system comprising: a first fluid transfer container (cell product package 100; Fig. 9), the first fluid transfer container including: a tube (housing 102; Fig. 8 and 9), the tube including a conical portion (tapered region 106; Fig. 8 and 9) at one end, the tube defining an interior space (product space 104; Fig. 8 and 9); one or more fluid passages (fluid pathways 112, ports 150 and 164; Fig. 8 and 9) configured to allow flow of fluid into or out of the interior space of the tube; a connector (closure device 124; Fig. 8 and 9) disposed at an end of the conical portion, the connector configured to seal the end of the conical portion when the connector is joined only to the conical portion (a septum or valve that may be pierced or opened by a tool such as a tube, projecting plug portion, pipette tip, syringe, needle, or other form of fluid connection means, para. [0179]); and a pressure control mechanism configured to increase or decrease a pressure in the interior space of the tube (para. [0179]; closure device 124 can be a valve that may be opened by a tool such as a tube, projecting plug portion, pipette tip, syringe, needle or other form of fluid connection means), but does not disclose the connector is configured to fluidly connect the first fluid transfer container to a second fluid transfer container.
McGillicuddy discloses analogous art related to two chambers connected and in fluid communication with each other, comprising a connector (female swabable Luer 48; Fig. 3C) disposed at an end of the conical portion of the first fluid transfer container, the connector configured to fluidly connect the first fluid transfer container to a second fluid transfer container (para. [0017]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid transfer system of Dodgson by replacing the tool access closure with the direct container to container connector taught by McGillicuddy for the purpose of fluid transfer in a closed system (para. [0017], McGillicuddy).
Regarding claim 2, the combination of Dodgson and McGillicuddy discloses wherein the connector (closure device 124, Fig. 9, Dodgson) includes at least part of a swabable valve (closure device 124 can be a valve that may be opened by a tool such as a syringe, and may be adapted to re-seal after opening, paras. [0179], [0193], [0291], Dodgson; female swabable Luer 48, Fig. 3C, McGillicuddy).
Regarding claim 3, the combination of Dodgson and McGillicuddy discloses a cap (outer sterile closure 126; Fig. 8, Dodgson) configured to cover the connector (closure device 124; Fig. 8 and 9, Dodgson). While the combination of Dodgson and McGillicuddy does not disclose a cap that covers at least part of the conical portion, it has been held that changes in size, shape, or proportion are generally considered obvious to one of ordinary skill in the art absent a showing of criticality or unexpected results. See MPEP 2144.04. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap of the combination of Dodgson and McGillicuddy to extend upward to cover not only the connector but also at least part of the conical portion. Such a modification constitutes a predicable variation motivated by routine design considerations of improving durability and sealing performance. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 4, the combination of Dodgson and McGillicuddy discloses wherein the cap is configured to be received in a centrifuge (para. [0180], [0206], Dodgson; para. [0014], McGillicuddy).
Regarding claim 6, the combination of Dodgson and McGillicuddy discloses a media supply (reservoir 172; Fig. 9, Dodgson) and a fluid line (fluid conduit 160; Fig. 9, Dodgson) connected to the media supply and to one of the one or more fluid passages (fluid pathway 112; Fig. 9, Dodgson).
Regarding claim 7, the combination of Dodgson and McGillicuddy discloses a vent (second fluid conduit 116; Fig. 9, the second fluid conduit may be adapted to allow flow of fluid into the product space to equalize wholly or partially changes of pressure; para. [0294], Dodgson) including a filter (breather means 120; Fig. 9, the second fluid pathway may be closed by a breather means such as a porous membrane or a valve; para. [0295], Dodgson), and a fluid line (product space 104; Fig. 9, Dodgson) connected to the vent and to one of the one or more fluid passages (fluid pathway 112; Fig. 9, Dodgson).
Regarding claim 9, the combination of Dodgson and McGillicuddy discloses wherein the pressure control mechanism is a syringe (one or more fluid pathways may extend to ports and connect to syringes, ports accept standard fluid connections such as Luer fittings; para. [0193], Dodgson) including a syringe tube, a plunger (the syringe tube and plunger are considered inherently and necessarily present in the disclosed syringe), and a luer connector (Luer fitting, para. [0193], Dodgson; female swabable Luer 48, Fig. 3C, McGillicuddy), the luer connector configured to be connected to a transfer container luer connector provided on the transfer container (since Luer fittings have female and male components, it is inherent that one Luer component is located on the syringe while the other is on the transfer container 100, Dodgson; male Luer, para. [0017], McGillicuddy).
Regarding claim 10, the combination of Dodgson and McGillicuddy discloses a second fluid transfer container including a second tube (patient administration means 182, Fig. 9, Dodgson; syringe 70, Fig. 3C, McGillicuddy), the second tube including a second conical portion at one end (Fig. 3C, McGillicuddy), the second tube defining a second internal space, and a second connector (male slip fit Luer 86; Fig. 3C, McGillicuddy), the connector configured to seal the end of the second conical portion when the connector is joined only to the second conical portion, wherein the connector of the first fluid transfer container and the second connector are configured to be joined to one another (para. [0109]; Fig. 3C, McGillicuddy), wherein the connector of the first fluid transfer container and the second connector are configured to be joined to one another (one or more fluid pathways may extend to ports and connect to syringes, ports accept standard fluid connections such as Luer fittings, para. [0193], since Luer fittings have female and male components, it is inherent that one Luer component is located on the syringe while the other is on the transfer container 100, Dodgson; also see para. [0017], McGillicuddy),
Regarding claim 11, the combination of Dodgson and McGillicuddy discloses wherein the connector of the first fluid transfer container forms a first portion of a swabable valve and the second connector forms a second portion of the swabable valve (closure device 124 can be a valve that may be opened by a tool such as a syringe, and may be adapted to re-seal after opening; paras. [0179], [291], one or more fluid pathways may extend to ports and connect to syringes, ports accept standard fluid connections such as Luer fittings; para. [0193], since Luer fittings have female and male components, it is inherent that one Luer component is located on the syringe while the other is on the transfer container 100, Dodgson; also see para. [0017], the Luer to Luer connection can include a female swabable Luer at one of the syringe sand a male slip fit Luer at the other of the syringes, McGillicuddy).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dodgson in view of McGillicuddy, as applied to claim 1 above, and further in view of Burton et al. (U.S. Patent Application Pub. No. 2005/0107757, hereinafter Burton).
Regarding claim 5, the combination of Dodgson and McGillicuddy does not disclose a vacuum source and fluid line connected to the transfer assembly and to one of the one or more fluid passages.
Burton discloses analogous art related to a medical vacuum aspiration system, comprising vacuum source (electric vacuum pump or manual vacuum pump, para. [0056]) and fluid line (aspiration cylinder 300, Fig. 1) connected to the transfer assembly and to one of the one or more fluid passages (fluid conduit 208, Fig. 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of the combination of Dodgson and McGillicuddy with the vacuum source as taught by Burton for the purpose of drawing fluid from a container (para. [0056], Burton).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dodgson in view of McGillicuddy, as applied to claim 1 above, and further in view of EP 3342436 (Heinz).
Regarding claim 8, the combination of Dodgson and McGillicuddy does not directly teach wherein the pressure control mechanism includes a plunger movably disposed within the tube, wherein: the one or more fluid passages are disposed on the plunger, the plunger includes a socket, and the pressure control mechanism further includes a plunger handle configured to be attached to the plunger at the socket, the plunger handle configured such that a space is formed between the plunger handle and the tube, the space configured to accommodate one or more fluid lines configured to be joined to the one or more fluid passages.
Heinz discloses analogous art related to device for receiving and removing liquids, wherein the pressure control mechanism includes a plunger (piston 3; Fig. 2) movably disposed within the tube (cylinder 1; Fig. 2), wherein: the one or more fluid passages (hole-shaped recess 4; Fig. 5) are disposed on the plunger, the plunger includes a socket (central cone 18; Fig. 5), and the pressure control mechanism further includes a plunger handle (closure cap 6; Fig. 2) configured to be attached to the plunger at the socket (Fig. 5), the plunger handle (closure cap 6; Fig. 2) configured such that a space is formed between the plunger handle and the tube, the space configured to accommodate one or more fluid lines (tube 5; Fig. 2) configured to be joined to one or more fluid passages (hole-shaped recess 4; Fig. 5). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of the combination of Dodgson and McGillicuddy with the pressure control mechanism taught by Heinz for the purpose of exact removal of individual phases (page 2 line 3 of machine translation of Heinz).
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 SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shuyi S. Liu/ Examiner, Art Unit 1774
/CLAIRE X WANG/ Supervisory Patent Examiner, Art Unit 1774