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 May 15, 2026. As directed by the amendment: claim 1 has been amended and claims 4-7 have been added. Thus, claims 1-7 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed May 15, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to Vailancourt not teaching or disclosing that no portion of the valve actuation member extends through the opening while transitioning the valve from a closed to open state. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claim 1 is objected to because of the following informalities: the claims should be amended to recite “a proximal surface in line 8 to provide antecedent basis for the claim terminology. 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.
Claims 4-5 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 claim 4, the claim recites that the valve comprises a proximal projection which spaces a contact surface from the valve. Since the proximal projection is a part of the valve, it is unclear how part of the valve can space the contact surface from itself. For examination purposes, the claim is interpreted to mean that the valving member comprises a proximal projection which spaces a contact surface from the valve as this interpretation appears supported by Applicant’s disclosure (see paragraph 86 of the published application).
Claim 5 is also rejected by virtue of being dependent on claim 4.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korogi (US 7559530) in view of Leinsing (US 20040127854).
Regarding claim 1, Korogi discloses an apparatus comprising:
a hub (female connector 79 in fig. 10) that defines a cavity (see below);
a core (tubular member 73 in fig. 8), the core comprising a valve actuation tip (see below), wherein at least a portion of the core is configured to be positioned within the cavity of the hub (fig. 10); and
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a valving member (elastic member 75 in fig. 8) comprising an attachment portion that is fixedly attached to the core (lower seal 11 in fig. 9) and a valve positioned distal to a proximal end of the cavity (see below) and proximal to the valve actuation tip of the core (the top surface of the valve below comprising slit 4 is proximal to the valve actuation tip in the closed state so that a portion of the valve is proximal to the valve actuation tip), the valve comprising a selectively sealable opening formed in the proximal surface (slit 4 in fig. 8), the valve being movable relative to the core such that as at least a portion of the valve moves distally, interaction between the valve and the valve actuation tip opens the valve to establish fluid communication between the cavity of the hub and the lumen of the catheter (fig. 10 shows the valve moving distal and against the valve actuation tip), but no portion of the valve actuation member extends through the selectively sealable opening in transitioning the valve from the closed state to the open state (fig. 10).
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However, Korogi does not teach or disclose a catheter that comprises a lumen, the core attached to the catheter.
In a separate embodiment (fig. 28), Korogi teaches a core (connector 260 in fig. 28) which is capable of connecting to a catheter (fig. 28; 10:63-65). Since Korogi teaches that the devices are intended for a multitude of device/uses (10:61-63), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the core of the first embodiment (fig. 8-10) to comprise the connector of the second embodiment (fig. 28) in order to attach the device to a standard IV tubing set, as envisioned by Korogi (10:61-65).
Leinsing teaches a similar device (fig. 3) comprising a core (adaptor 46 in fig. 3) which further comprises a catheter comprising a lumen (catheter 36 in fig. 3) attached to the core (fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of modified Korogi to further comprise a catheter comprising a lumen and attached to the connector of the core of modified Korogi. This modification would enable the apparatus of modified Korogi to infuse fluid intravenously to the patient, as envisioned by Korogi (10:61-65).
Regarding claim 2, in the modified apparatus of Korogi, Korogi discloses the core is movable relative to the hub from a retracted position to an advanced position (the core is movable relative to the hub by threading/untreading the housing component to/from the connector 79 with the detached condition in fig. 9 being the “retracted position” and the attached condition in fig. 10 being the “advanced position”).
Regarding claim 3, in the modified apparatus of Korogi, Korogi discloses the hub is configured to securely couple with the core when the core is moved to the advanced position (the connector 79 is indirectly secured to the core by engaging threaded elements 83 of housing component 89).
Regarding claim 4, Korogi discloses an apparatus comprising:
a hub (female connector 79 in fig. 10) that defines a cavity (see below);
a core (tubular member 73 in fig. 8), the core comprising a valve actuation tip (see below), wherein at least a portion of the core is configured to be positioned within the cavity of the hub (fig. 10); and
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a valving member (elastic member 75 in fig. 8) comprising an attachment portion that is fixedly attached to the core (lower seal 11 in fig. 9) and a valve positioned distal to a proximal end of the cavity (see below) and proximal to the valve actuation tip of the core (the top surface of the valve below comprising slit 4 is proximal to the valve actuation tip in the closed state so that a portion of the valve is proximal to the valve actuation tip),
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wherein the valve comprises a proximal projection (lugs 77 in fig. 10 are projections and have a proximal facing surface) that spaces a contact surface (surface 80 in fig. 12 of connector 79) from the valve (see below; surface 80 engages the proximal facing surface of the lugs to space the contact surface below from a portion of the valve below) and a proximal surface that is recessed in a distal direction relative to the contact surface (see below, the surface below is recessed in a distal direction relative to the surface below when the connector 79 is not attached), the valve being movable relative to the core such that as at least a portion of the valve moves distally, interaction between the valve and the valve actuation tip opens the valve to establish fluid communication between the cavity of the hub and the lumen of the catheter (fig. 10).
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However, Korogi does not teach or disclose a catheter that comprises a lumen, the core attached to the catheter.
In a separate embodiment (fig. 28), Korogi teaches a core (connector 260 in fig. 28) which is capable of connecting to a catheter (fig. 28; 10:63-65). Since Korogi teaches that the devices are intended for a multitude of device/uses (10:61-63), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the core of the first embodiment (fig. 8-10) to comprise the connector of the second embodiment (fig. 28) in order to attach the device to a standard IV tubing set, as envisioned by Korogi (10:61-65).
Leinsing teaches a similar device (fig. 3) comprising a core (adaptor 46 in fig. 3) which further comprises a catheter comprising a lumen (catheter 36 in fig. 3) attached to the core (fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of modified Korogi to further comprise a catheter comprising a lumen and attached to the connector of the core of modified Korogi. This modification would enable the apparatus of modified Korogi to infuse fluid intravenously to the patient, as envisioned by Korogi (10:61-65).
Regarding claim 5, in the modified apparatus of Korogi, Korogi teaches the valve further comprises a selectively sealable opening formed in the proximal surface (slit 4 in fig. 8).
Regarding claim 6, Korogi discloses an apparatus comprising:
a hub (female connector 79 in fig. 10) that defines a cavity (see below);
a core (tubular member 73 in fig. 8), the core comprising a valve actuation tip (see below), wherein at least a portion of the core is configured to be positioned within the cavity of the hub (fig. 10); and
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a valving member (elastic member 75 in fig. 8) comprising an attachment portion that is fixedly attached to the core (lower seal 11 in fig. 9) and a valve positioned distal to a proximal end of the cavity (see below) and proximal to the valve actuation tip of the core (the top surface of the valve below comprising slit 4 is proximal to the valve actuation tip in the closed state so that a portion of the valve is proximal to the valve actuation tip), the valve comprising a selectively sealable opening formed in the proximal surface (slit 4 in fig. 8), the valve being movable relative to the core such that as at least a portion of the valve moves distally, interaction between the valve and the valve actuation tip opens the valve to establish fluid communication between the cavity of the hub and the lumen of the catheter (fig. 10 shows the valve moving distal and against the valve actuation tip).
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However, Korogi does not teach or disclose a catheter that comprises a lumen, the core attached to the catheter, wherein a proximal end of the catheter is received within a lumen of the core,.
In a separate embodiment (fig. 28), Korogi teaches a core (connector 260 in fig. 28) which is capable of connecting to a catheter (fig. 28; 10:63-65). Since Korogi teaches that the devices are intended for a multitude of device/uses (10:61-63), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the core of the first embodiment (fig. 8-10) to comprise the connector of the second embodiment (fig. 28) in order to attach the device to a standard IV tubing set, as envisioned by Korogi (10:61-65).
Leinsing teaches a similar device (fig. 3) comprising a core (adaptor 46 in fig. 3) which further comprises a catheter comprising a lumen (catheter 36 in fig. 3) attached to the core (fig. 3), wherein a proximal end of the catheter is received within a lumen of the core (fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of modified Korogi to further comprise a catheter comprising a lumen and attached to the connector of the core of modified Korogi so that a proximal end of the catheter is received within a lumen of the core. This modification would enable the apparatus of modified Korogi to infuse fluid intravenously to the patient, as envisioned by Korogi (10:61-65).
Regarding claim 7, in the modified apparatus of Korogi discloses a proximal tip of the catheter is distally recessed relative to the valve actuation tip (in modified Korogi, the proximal tip of the catheter would be positioned within the lumen below so that the catheter tip is distal relative to the valve actuation tip in fig. 28).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Doyle (US 20030136932) discloses an apparatus comprising a hub with a cavity (element 28 in fig. 12), a core (male luer 10 in fig. 6 and 12) comprising a valve actuation tip (support 54 in fig. 12), and a valving member (bladder member 56 in fig. 11/12) having an attachment portion (distal flange in fig. 12) and a valve (forward end portion 58 in fig. 12) having a selectively sealable opening (slit in fig. 11/12).
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 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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