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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/2026 has been entered.
Claim Rejections - 35 USC § 102
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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meng et al. (PG PUB 2010/0217209).
Re claim 1, Meng discloses a fluid connector assembly (Fig 1) for a medical fluid (Para 45) comprising: a housing 103 (Fig 1) comprising an internal chamber (within which valve component 105 resides in Fig 1; “interior lumen of the tube 103”, Para 44) that forms a fluid path for the medical fluid (Para 45); and a valve component 105 (Fig 1; seen in explosion in Fig 2 and in operation in Fig 3A-3C) disposed in the internal chamber (as seen in Fig 1), the valve component comprising: an inner portion (the portion of valve plate 205 radially inward of the valve plate’s openings, identified in Fig A below by the dashed circle), an outer portion (the combination of pressure limiter 201, spacer plate 203, valve seat 207 and the part of valve plate 205 that resides outside the openings) that surrounds the inner portion (as seen in Fig 2,3A-3C; it is noted that the pressure limiter 201 in Fig 3A-3C is 307, the spacer plate 203 in Fig 3A-3C is 305, the valve seat 207 in Fig 3A-3C is 301, and the valve plate 205 in Fig 3A-3C is 303), and at least one flexible ledge (formed between the openings of valve plate 205, identified in Fig A below using shade) that connects the inner portion with the outer portion (as seen in Fig 2) such that the inner portion is movable relative to the outer portion (as seen in comparison of Fig 3A-3C, Para 50), wherein the inner portion is suspended from the outer portion by the at least one flexible ledge to form a valve chamber between the outer portion and the inner portion (as seen in Fig 3A-3B, an inflow valve chamber is formed between the valve plate 205/303 and the valve seat 207/301 and an outflow valve chamber is formed between the valve plate 205/303 and the pressure limiter 201/307; the outflow chamber is considered the “valve chamber” of the claim), and the inner portion is movable between i) a first position (seen in Fig 3B), wherein the inner portion is separated from the outer portion and permits the medical fluid to move through the valve chamber (Para 50), and ii) a second position (seen in Fig 3C), wherein the inner portion contacts the outer portion (as seen in Fig 3C, the first portion contact ring 215 of pressure limiter 201) to seal the valve chamber and close the fluid path to resist movement of the medical fluid through the valve chamber (Para 50,51), wherein the inner portion, the outer portion, and the at least one flexible ledge are formed from a flexible material (the plate 205 which forms the entirety of the inner portion and the at least one flexible ledge and forms a part of the outer portion is disclosed in Para 16,47 as being “flexible” and in Para 49 as being formed from “silicone”), wherein the at least one flexible ledge provides a separation between the inner portion and the outer portion that defines the valve chamber (as seen in Fig 3B, the at least one ledge longitudinally separates the inner portion from the pressure limiter 307 of the outer portion and this separation defines the longitudinal length of the valve chamber), and defines a threshold force at which the inner portion moves from the first position to the second position (the degree of flexibility of the plate 205 as a whole (which includes the at least one flexible ledge) defines the threshold force that is required to move the inner portion from the first position to the second position, Para 50,51).
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Re claim 2, Meng discloses that the valve component comprises: a first surface (the surface belonging to valve plate 205/303 and facing downward in Fig 3A-3C) comprising a plurality of first surface openings (labeled in Fig A above); and a second surface (belonging to pressure limiter 201/307 and facing upward in Fig 3A-3C) opposite the first surface, the second surface comprising a second surface opening 209 (Fig 2) fluidly connected to the plurality of first surface openings when the inner portion is in the first position (Para 50).
Re claim 3, Meng discloses that an external force provided by the medical fluid to the first surface causes the inner portion to move relative to the outer portion (Para 50).
Re claim 4, Meng discloses that the inner portion is separated from the outer portion by the valve chamber (as seen in Fig 3B), and responsive to the external force exceeding a threshold force, the inner portion is in the second position (Para 50,51).
Re claim 5, Meng discloses that a portion of the first surface is defined by the inner portion (as explained in the rejection of claim 2 above) and has a first area (the total area of the inner portion facing downward in Fig 3A-3C), and the inner portion extends from the first surface toward the second surface (as seen in Fig 3A,3B, the inner portion has a thickness that extends upward toward the second surface) such that the inner portion has a second area (a partial area of the inner portion facing upward in Fig 3A-3C) near the second surface (as seen in Fig 3A), and wherein the first area is greater than the second area (as seen in Fig 3A, the inner portion is cylindrical in shape, thus the total area of the inner portion facing downward in Fig 3A-3C is greater than a partial area of the inner portion facing upward in Fig 3A-3C).
Re claim 6, Meng discloses that the valve component comprises a cylindrical valve component (as seen in Fig 2).
Re claim 7, Meng discloses that the at least one ledge comprises a plurality of flexible ledges (as seen in Fig 2 and annotated Fig A above, there are four ledges) that connect the inner portion with the outer portion (as seen in Fig A and Fig 3A-3C).
Re claim 8, Meng discloses a fluid connector assembly (Fig 1) for a medical fluid (Para 45), comprising: a housing 103 (Fig 1) comprising a housing chamber (within which valve component 105 resides in Fig 1; “interior lumen of the tube 103”, Para 44); and a valve component 105 (Fig 1; seen in explosion in Fig 2 and in operation in Fig 3A-3C) disposed in the housing chamber (as seen in Fig 1), the valve component comprising: a first portion (the portion of valve plate 205 radially inward of the valve plate’s openings, identified in Fig A above by the dashed circle), a second portion (the combination of pressure limiter 201, spacer plate 203, valve seat 207 and the part of valve plate 205 that resides outside the openings) that surrounds the first portion (as seen in Fig 2,3A-3C; it is noted that the pressure limiter 201 in Fig 3A-3C is 307, the spacer plate 203 in Fig 3A-3C is 305, the valve seat 207 in Fig 3A-3C is 301, and the valve plate 205 in Fig 3A-3C is 303), an a plurality of flexible ledges (formed between the openings of valve plate 205, identified in Fig A above using shade) that connect the first portion with the second portion such that the first portion is movable relative to the second portion (as seen in comparison of Fig 3A-3C, Para 50), wherein the first portion is suspended from the second portion by the plurality of flexible ledges to form a valve chamber disposed between the first portion and the second portion (as seen in Fig 3A-3B, an inflow valve chamber is formed between the valve plate 205/303 and the valve seat 207/301 and an outflow valve chamber is formed between the valve plate 205/303 and the pressure limiter 201/307; the outflow chamber is considered the “valve chamber” of the claim), and responsive to receiving the medical fluid, the first portion moves relative to the second portion from an open position (seen in Fig 3B) in which the medical fluid is permitted to pass through the valve chamber (Para 50) to a closed position (seen in Fig 3C) in which the first portion contacts the second portion (as seen in Fig 3C, the first portion contacts ring 215 of pressure limiter 201) and closes the valve chamber (Para 50,51), wherein the inner portion, the outer portion, and the at least one flexible ledge are formed from a flexible material (the plate 205 which forms the entirety of the inner portion and the at least one flexible ledge and forms a part of the outer portion is disclosed in Para 16,47 as being “flexible” and in Para 49 as being formed from “silicone”), wherein the at least one flexible ledge provides a separation between the inner portion and the outer portion that defines the valve chamber (as seen in Fig 3B, the at least one ledge longitudinally separates the inner portion from the pressure limiter 307 of the outer portion and this separation defines the longitudinal length of the valve chamber), and defines a threshold force at which the inner portion moves from the first position to the second position (the degree of flexibility of the plate 205 as a whole (which includes the at least one flexible ledge) defines the threshold force that is required to move the inner portion from the first position to the second position, Para 50,51).
Re claim 9, Meng discloses that the valve component comprises a cylindrical valve component (as seen in Fig 2).
Re claim 10, Meng discloses that, prior to an external force provided by the medical fluid, the first portion is separated from the second portion by a threshold force (as seen in Fig 3B, Para 50), and when the external force is at least at the threshold force, the first portion contacts the second portion (as seen in Fig 3C, Para 50,51).
Re claim 11, Meng discloses that the valve component comprises: a first surface (belonging to valve plate 205/303 and facing downward in Fig 3A-3C) comprising a plurality of first surface openings (labeled in Fig A above); and a second surface (belonging to the pressure limiter 201/307 and facing upward in Fig 3A-3C) opposite the first surface (as seen in Fig 3A-3C), the second surface comprising a second surface opening 209 (Fig 2) fluidly connected to the plurality of first surface openings by the valve chamber prior to the external force being at least at the threshold force (Para 50).
Re claim 12, Meng discloses that the first portion moves relative to the second portion based on the first surface receiving the medical fluid (Para 50,51).
Re claim 13, Meng discloses that the plurality of flexible ledges comprises four ledges (as seen in Fig 2 and Fig A above).
Re claim 14, Meng discloses that the second portion remains stationary when the first portion moves (as seen in Fig 3B to 3C; Para 50).
Response to Arguments
Applicant’s arguments filed 9/2/2026 have been considered but are not persuasive. Applicant argues (1) that Meng’s “valve plate 205 is not disclosed as providing the separation that defines the alleged valve chamber” and (2) “is not disclosed as defining the force at which the alleged inner portion moves into contact with the alleged outer portion”, instead “Meng attributes both [of these characteristics] to the spacer plate 203”. The Examiner respectfully disagrees. Re argument (1), although spacer plate 203 does indeed separate valve plate 205 longitudinally from pressure limiter 201 (which is considered part of the claimed “outer portion”) and does indeed define a part of the circumferential wall that forms the “valve chamber”, this does not negate the fact that the valve plate 205 (which possesses the at least one flexible ledge) also “defines the valve chamber” as claimed since it defines the lower boundary of the valve chamber (as seen in Fig 3b,3c). It is noted that the claim does not require the at least one flexible ledge be the only structure that “defines the valve chamber”. Re argument (2), although spacer plate 203 may “set the closing pressure” due to its thickness (as set forth by Meng in Para 51), the flexibility of the valve plate 205 also at least partially “defines the threshold force” as claimed because a valve plate having lower flexibility would require higher force to deform than a valve plate having a higher flexibility. It is noted that the claim does not require that the at least one flexible ledge be the only feature that “defines [the] threshold force”.
Regarding Applicant’s request for rejoinder of withdrawn claims 15-20, rejoinder will be considered if/when any of the non-withdrawn claims are in condition for allowance, as set forth in MPEP § 821.04. Since no claims are currently in condition for allowance, reconsideration of rejoinder is not appropriate at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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