DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that there is no . This is not found persuasive because the inventions require a different field of search due to the divergent subject matter which would require differing subclasses and text search queries. It is additionally pointed out that, the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 26, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 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 § 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 3-8, 34, and 35 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.
Regarding claims 3 and 34, the claim recites “the base of the plug”. There is insufficient antecedent basis for this limitation. It is unclear if this limitation is directed towards the base of the connector or if it is a separate base. For examination purposes, the first interpretation was used.
Claims 4-8 and 35 are also rejected by virtue of being dependent on claims 3 and 34.
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.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakamoto (US 5699936).
Regarding claim 9, Sakamoto discloses a bladder assembly (fig. 3) comprising:
a flexible material defining a sealed expandable chamber (container body 12 in fig. 3; 3:16-19 discloses a flexible material), the flexible material defining a fluid flow port passing from an interior volume of the sealed expandable chamber to an outside of the sealed expandable chamber (aperture 27 in fig. 2); and
a connector attached to the flexible material and at least partially in the fluid flow port (dispenser system 14 in fig. 3), the connector including,
a base (flange 18 in fig. 3), and
a plug protruding from the base (tube member 20 in fig. 3), the connector defining a connector lumen through the base and the plug (fig. 3), the connector lumen providing a fluid flow path from the interior volume of the sealed expandable chamber to an outside of the flexible material (when closed end portion 28 is snapped off via score 34, a fluid flow path exists through the lumen to connect the interior of the expandable chamber and the outside).
Regarding claim 10, Sakamoto discloses the connector is attached to the flexible material via a seal surrounding the fluid flow port and joining a portion of the flexible material to the base of the connector (3:21-27 discloses an adhesive between the flange 18 and the container body 12 to seal the dispenser system 14 to the container body; it is understood that the adhesive would at least partially surround the aperture 27).
Claim(s) 32 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitchell (US 20050101939).
Regarding claim 32, Mitchell discloses an interconnection assembly (fig. 1) comprising:
a receiver (part 14 in fig. 1) including, a body (socket portion 60 in fig. 1) defining a receptacle (see below) and a receiver lumen extending between a first side of the body to second side of the body (see vertical arrow below), the receiver lumen having a lumen axis (vertical lumen axis below), and
a latch plate slidably attached to the body (retaining plate 108 is slidable against the bias of spring 126 in fig. 1), the latch plate defining an aperture having an aperture axis parallel to the lumen axis (opening 112 in fig. 3 is vertically arranged in order to allow plug 22 to pass therethrough so as to be parallel to the vertically arranged lumen axis); and
a connector (part 12 in fig. 1) including, a base (tubular body 20 in fig. 1), a plug protruding from the base (plug 22 in fig. 1), the connector defining a connector lumen through the base and the plug (fig. 1).
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Regarding claim 34, Mitchell discloses the plug further includes, a recess offset a first distance from the base of the plug (peripheral grooves 26 in fig. 1), and a compliant portion arranged around a periphery of the plug (O-ring 30 in fig. 1), the compliant portion configured to create a seal between the plug and the receptacle (it is understood that when plug 22 is inserted into the receptacle denoted above, a seal exists due to the O-ring 30), the compliant portion offset a second distance from the base (O-ring 30 is offset the same distance as the first distance; the examiner notes that the present claim language does not require the distances to be different).
Claim Rejections - 35 USC § 103
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.
Claim(s) 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell, as applied to claims 32 and 34 above, and further in view of Hachey (US 9849236).
Regarding claim 33, Mitchell discloses all of the claimed limitations set forth in claim 32, as discussed above, but does not teach or disclose a bladder defining an expandable chamber and a fluid flow port passing from an interior volume of the expandable chamber to an outside of the bladder, wherein the connector is operatively attached to the fluid flow port such that the connector lumen provides a fluid flow path from the interior volume of the expandable chamber to an outside of the bladder.
Hachey teaches an interconnection assembly (fig. 2) comprising a bladder defining an expandable chamber (IV bag 210 in fig. 2) and a fluid flow port passing from an interior volume of the expandable chamber to an outside of the bladder (port 280 in fig. 2 allows fluid to flow from bag 210 to a connector 160), wherein a connector is operatively attached such that the connector lumen provides a fluid flow path from the interior volume of the expandable chamber to an outside of the bladder (connector 150 in fig. 1).
Hachey further teaches that the connector (connector 150 in fig. 1) is attached to a receiver (connector 160 in fig. 1) so as to form a two-part interconnection assembly in a similar manner to that of Mitchell. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the assembly to Mitchel to further comprise the claimed bladder, as taught by Hachey. This modification would enable delivery of IV fluids to a patient.
Regarding claim 35, Mitchell discloses all of the claimed limitations set forth in claims 32 and 34, as discussed above, and further discloses that the compliant portion is a ridge protruding from the plug (O-ring 30 in fig. 1). While O-rings are generally understood to be elastically flexible, Mitchell does not explicitly teach or disclose this limitation.
Hachey teaches a similar compliant portion (O-ring 407 in fig. 3) which is elastically flexible (9:8-10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the compliant portion of Mitchell to be elastically flexible, as taught by Hachey, as this type of material is well known in O-rings as it enables the O-ring to be stretched over the stem (9:8-10).
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 20080275422) in view of Witt (US 5071104) and in further view of Hachey.
Regarding claim 26, Ross discloses a selective coupling assembly comprising:
a receiver (connector 32 in fig. 3) at least partially within a wall of a bladder holder (figs. 2 and 3 shows the connector within an aperture 36 of the wall of holder 20),
a bladder defining an expandable chamber (bellows 40 in fig. 4B) and a fluid flow port passing from an interior volume of the expandable chamber to an outside of the bladder (see below); and
a connector attached to the bladder (tube 44 in fig. 4B), the connector including, a base (tube 44 in fig. 4B), a plug protruding from the base (see below), the connector defining a connector lumen through the base and the plug (paragraph 42), the connector lumen providing a fluid flow path from the interior volume of the expandable chamber to an outside of the bladder (paragraph 42).
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While it appears that the base (tube 44 in fig. 4B is partially within the port above, Ross does not explicitly disclose this feature as well as a plug protruding from the base. Additionally, Ross does not teach or disclose the receiver including, a body defining a receptacle and a first lumen extending from a first side of the body to a second side of the body, the first lumen having a lumen axis, and a latch plate slidably attached to the body, the latch plate defining an aperture and having an aperture axis parallel to the lumen axis.
Witt teaches a similar bladder (bladder 20 in fig. 3) comprising a fluid flow port (see below) and a connector (see below) having a base (tube 24 in fig. 2) received within the fluid flow port (fig. 3 shows the tube extending into the port below) and a plug extending from the base (see below).
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Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the base of Ross to be partially within the fluid flow port of Ross in order to fluidically couple the base to the bladder and to further include the plug extending from the base, as taught by Witt. This modification would enable the connector to couple to a pressure gauge and pressure infuser.
Hachey teaches a similar infusion bag as Ross (container 210 in fig. 2) comprising a receiver attached to the bag (luer connector 160 in fig. 2). Hachey teaches that the receiver comprises a body (housing 490 in fig. 3) defining a receptacle (see below) and a first lumen extending from a first side of the body to a second side of the body (passageway 498 in fig. 3), the first lumen having a lumen axis (fig. 3 shows a vertical axis), and a latch plate slidably attached to the body (see below; top of seal element 496 forms a plate), the latch plate defining an aperture (slit 502 in fig. 3) and having an aperture axis parallel to the lumen axis (when the slit is open the aperture axis is a vertical axis).
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Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the receiver of Ross to be the receiver of Hachey for the purpose of providing an equivalent resealable and releasable receiver which also provides the advantage of being needleless to prevent inadvertent pricks.
Regarding claim 27, in the modified assembly of Ross, Ross discloses the bladder is configured to be moved from a first position outside of the bladder holder to a second position inside the bladder holder (the bellows 40 in fig. 4B can be removed from the housing 20 by opening lid 26), and the receiver is at least partially within the bladder holder (fig. 4A shows the receiver 32 partially received within the housing 20).
Allowable Subject Matter
Claims 1 and 2 are allowed.
Claims 3-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 28-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record is Ross in view of Hachey.
Regarding independent claim 1, Ross in view of Hachey fails to teach among all the limitations or render obvious a bucket including, a wall extending from an open end of the bucket to a closed end of the bucket, the wall at least partially defining a cavity between the open end and the closed end,
Regarding claim 28, Ross in view of Hachey fails to teach or disclose the connector is configured to be moved between a lock state with the receiver and an unlocked state with the receiver, in combination with the total structure and function as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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