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 .
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 Objections
Claims 1, 7, and 11 are objected to because of the following informalities:
Regarding claims 1, 7, and 11, the claims should be amended to recite “a first medical device in lines 12, 16, and 14, respectively, 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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 10, all of the limitations set forth in claim 10 is already recited in claim 7 so that the claim fails to further limit claim 7.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 body 1invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West (US 20190053980).
Regarding claim 1, West discloses a medical connector (adaptor 10 in fig. 2) comprising:
a first connection member (inner member 28 in fig. 6) having a first connection port (connector 12 in fig. 6), and a second connection port that fluidically communicates with the first connection port (distal end of needle cannula 25 in fig. 6);
a second connection member (housing 16 in fig. 3); and
a ratchet mechanism portion that couples the first connection member and the second connection member (paragraph 55; figs. 8 and 9 shows ratchet teeth located on member 28 and housing 16), wherein:
the first connection member is configured such that, upon performance of a first connection operation in which the second connection member rotates, the first connection member co-rotates via the ratchet mechanism portion to allow the first connection port to be fluidically connected to the first medical device and allow the first connection member to be mechanically connected to the first medical device (paragraph 58 discloses that in rotation direction A, the corresponding ratchet teeth between the inner member 28 and housing 16 engage in a way so that the two elements are forced to rotate together),
the second connection member is configured such that, upon performance of a second connection operation, the second connection member is mechanically connected to a second medical device to allow the second connection port to be fluidically connected to the second medical device without the second connection member being located between the second connection port and the second medical device (the examiner notes that the second medical device is functional and not positively recited; a second medical device is configured to mechanically engage housing 16 and to be in fluid communication with member 28; see fig. 1 which appears to show such an arrangement), and
the second connection member is configured such that, upon rotation of the second connection member in a direction opposite to the rotation during the first connection operation, the second connection member idles with respect to the first connection member via the ratchet mechanism portion (paragraph 58 discloses that the inner member 28 is allowed to freely rotate relative to housing 16 due to angled portions 41a in a direction B which is opposite to direction A).
Regarding claim 2, Guala discloses the first connection member comprises a female connector having the first connection port (female luer lock connector 12 in fig. 6).
Regarding claim 3, Guala discloses the first connection member comprises a spike having the second connection port (needle cannula 25 in fig. 6).
Regarding claim 4, Guala discloses a valve body (septum 17, holding member 19, and spring 21 in fig. 6) comprising a head portion (septum 17 in fig. 6) and a body portion (spring 21 in fig. 6), the head portion being movable by elastic deformation of the body portion in a longitudinal direction of the spike between a closing position in which the second connection port is closed (fig. 6) and an opening position in which the second connection port is open (paragraph 51).
Claim(s) 1, 2, 6, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guala (US 20170120031)
Regarding claim 1, Guala discloses a medical connector (fig. 1) comprising:
a first connection member (female connection member 3 in fig. 3) having a first connection port (see below), and a second connection port that fluidically communicates with the first connection port (see below);
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a second connection member (hollow body 1 in fig. 3); and
a ratchet mechanism portion that couples the first connection member and the second connection member (fig. 7; paragraph 48), wherein:
the first connection member is configured such that, upon performance of a first connection operation in which the second connection member rotates, the first connection member co-rotates via the ratchet mechanism portion to allow the first connection port to be fluidically connected to the first medical device and allow the first connection member to be mechanically connected to the first medical device (paragraph 48 discloses that the female connector 3 is coupled in rotation with hollow body 1 in screwing direction G which corresponds to the direction to screw female connector 3 onto a corresponding male connector 2),
the second connection member is configured such that, upon performance of a second connection operation, the second connection member is mechanically connected to a second medical device to allow the second connection port to be fluidically connected to the second medical device without the second connection member being located between the second connection port and the second medical device (fig. 3 shows hollow body 1 mechanically engaged to a male connector 2, equated to the claimed second medical device, which is fluidically connected to the second port above; fig. 3 shows the hollow body assembled to the male connector with this “assembling” being the “second connection operation”), and
the second connection member is configured such that, upon rotation of the second connection member in a direction opposite to the rotation during the first connection operation, the second connection member idles with respect to the first connection member via the ratchet mechanism portion (paragraph 48 and fig. 7 shows that the hollow body 1 can rotate in an opposite direction to G relative to the female connector 3).
Regarding claim 2, Guala discloses the first connection member comprises a female connector having the first connection port (fig. 3).
Regarding claim 6, Guala discloses the second connection member comprises a locking claw portion configured to be mechanically connected to the second medical device by elastic deformation (fig. 5 shows the hollow body 1 comprises teeth 12 which elastically engage teeth 13 of the male connector 2).
Regarding claim 11, Guala discloses a method of using a medical connector, the method comprising:
providing the medical connector (fig. 1), which comprises:
a first connection member (male connector 2 in fig. 1) having a first connection port, and a second connection port that fluidically communicates with the first connection port (see below),
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a second connection member (hollow body 1 in fig. 3), and
a ratchet mechanism portion that couples the first connection member and the second connection member (fig. 5 and paragraph 45);
performing a first connection operation in which the second connection member rotates, upon which the first connection member co-rotates via the ratchet mechanism portion to allow the first connection port to be fluidically connected to the first medical device and allow the first connection member to be mechanically connected to the first medical device (paragraphs 45 and 46 discloses that the hollow body 1 can rotate with the male connector 2 in a direction opposite to F in fig. 5 to connect the male connector to a complementary female connector); and
performing a second connection operation in which the second connection member is mechanically connected to a second medical device to allow the second connection port to be fluidically connected to the second medical device without the second connection member being located between the second connection port and the second medical device (fig. 3 and paragraph 40 discloses that a female connector 3 is “mounted” to hollow body 1 with this “mounting” being the “second connection operation” so that the hollow body 1 is mechanically connected to female connector 3 which is fluidically connected to male connector 2); wherein:
the second connection member is configured such that, upon rotation of the second connection member in a direction opposite to the rotation during the first connection operation, the second connection member idles with respect to the first connection member via the ratchet mechanism portion (paragraph 45 and fig. 5 discloses that upon rotating hollow body 1 in a direction F, the teeth 12 slip over teeth 13 to allow relative rotation between hollow body 1 and male connector 2).
Allowable Subject Matter
Claims 7-9 are allowed.
Claim 5 is 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 following is an examiner' s statement of reasons for allowance/reasons for indicating allowable subject matter: The claims in this application are allowed/allowable because the prior art of record fails to disclose either singly or in combination the claimed medical connector.
The closest prior art of record is West.
Regarding independent claim 7, West fails to teach among all the limitations or render obvious a locking claw portion configured to be mechanically connected to a second medical device by elastic deformation, in combination with the total structure and function as claimed. West teaches the second connection member comprises a locking claw portion (see below). However, there is no indication that the locking claw portion below is configured to elastically deform to mechanically connect to a second medical device.
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Regarding claim 5, the closest prior art is West which fails to teach or disclose an engagement claw portion configured to be pushed and elastically deformed radially inward toward the spike by moving integrally with the head portion of the valve body on a root side of the spike and to engage with the second medical device. West teaches an engagement claw portion (see above). However, there is no indication that the engagement claw portion above is configured to elastically deform. Additionally, even if the engagement claw portion is configured to elastically deform, the engagement claw portion above would deform outwardly away from the spike as the second medical device is attached and not inwardly, as required by the claim.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clark (US 20140265319) discloses a medical connector comprising a first connection member (first member 4 in fig. 4A), a second connection member (second member 6 in fig. 1), and a ratchet mechanism portion (paragraph 44).
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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