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
The claims contain amendments that have not been marked in the manner required by 37 C.F.R. 1.121. Specifically, claims 5, 7, 9 and 13 include added text that has not been underlined. If the claims are amended in the future, all amendments must be indicated in the manner required by 37 C.F.R. 1.121.
Claim Objections
Claim 7 is objected to because of the following informalities: The term “flexible” should be inserted before the term “ledge” on line 2 to match the language of claim 1 and ensure consistent claim language. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The term “the” should be inserted before the phrase “valve component’ on line 1 in order to be grammatically correct. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The term “flexible” should be inserted before the term “ledges” on line 2 to match the language of claim 8 and ensure consistent claim language. Appropriate correction is required.
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.
Claim 5 is 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 has been amended to recite “wherein a portion of the first surface defined by the inner portion has a first area, and a portion of the second surface defined by the inner portion has a second area”.
This language renders it unclear whether the inner portion entirely defines the first surface or if the inner portion only partially defines the first surface. In other words, it is unclear if the claim intends to limit the first surface to being only on the inner portion or not. For the sake of examination, the claim is interpreted such that the first surface is only partially defined by the inner portion.
Additionally, it remains unclear how the “second surface” can belong to the “inner portion” as claimed based on the Drawings and the rest of the Specification. Specifically, the Specification defines the “inner portion” with reference character 122, the “outer portion” with reference character 124, the “second surface” with reference number 144, and the “second surface opening” with reference number 148 (all reference characters seen in Fig 8). As seen in Fig 8, the second surface 144 does not appear to belong to the inner portion 122, but rather to the outer portion 124; this is also supported by Para 46 of the specification that sets forth that inner portion 122 is suspended from the outer portion 124 by means of ledges 136,138,140,142. It is noted that surface 150 belongs to the inner portion 122 (Fig 8, Para 50), but surface 150 cannot read on the “second surface” because surface 150 does not comprise “a second surface opening” as required by claim 2 and does not have an area that is less than the area of the inner portion 122 defined by the first surface 126 as required by claim 5. Because of this, it is unclear how a portion of the second surface is “defined by the inner portion” as claimed.
For the sake of examination, claim 5 is interpreted as reciting “wherein a portion of the first surface is defined by the inner portion and has a first area, and wherein the inner portion extends from the first surface toward the second surface such that an area of the inner portion near the second surface” since this is supported by the Drawings and the rest of the Specification.
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 (the valve chamber being formed between valve plate 205/303 and pressure limiter 201/307), 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).
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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 wherein 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 first area is greater than an area (a partial area of the inner portion facing upward in Fig 3A-3C) of the inner portion near the second surface (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).1
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 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 (the valve chamber being formed between valve plate 205/303 and pressure limiter 201/307), 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).
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 ledges comprises four (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 6/2/2026 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.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 See the 112(b) rejection above for an explanation of this interpretation.
Prosecution Insights