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 .
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.
Claim(s) 19-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masuda et al (US 6,296,621).
Regarding claim 19, Masuda discloses a port for establishing fluid communication between: (i) at least one fluid line of a medical treatment apparatus (intended use, such as line 2 in fig 3), which fluid line is assigned to an interior of the medical treatment apparatus, and (ii) a connector of a fluid line of a disposable (intended use, such as 1 in fig 3), wherein the fluid line is assigned to an exterior of the medical treatment apparatus, the port comprising: a first fluid guide 5 with at least a first lumen and a first end-side opening (fig 3), provided for receiving and/or guiding a medical fluid and for establishing the fluid communication with the connector (fig 3); and a second fluid guide 26 having at least a second lumen and a second end-side opening (fig 3, bottom), the second fluid guide comprising an entry point configured to be connected an air source (the upper end is an opening, which may be connected to an air source through intermediate structures such as line 1, socket 3, even cannula 18) and a drain configured to be connected to a discharge line of the medical treatment apparatus (the part of the bottom of guide/chamber 26 that attaches to line 2; to clarify the port is the opening in the bottom of guide/chamber 26 and attachment part being which line 2 attaches to the guide/chamber 26 is the chamber), wherein the first end-side opening of the first fluid guide is arranged, at least in sections, in the second lumen of the second fluid guide (fig 3).
Regarding claim 20, wherein the second end-side opening of the second fluid guide has a cross-sectional area smaller than a cross-sectional area of the second lumen arranged farther towards the interior of the medical treatment apparatus than the second end-side opening (fig 3, see tapered shape, especially toward outlet).
Regarding claim 21, wherein the outer diameter of the first fluid guide is constant (fig 3; when first fluid guide is considered small cylindrical part).
Regarding claim 22, wherein the outer diameter of the first fluid guide is constant in a region in which the cross-sectional area of the second lumen increases axially (fig 3, first guide is in tapered section).
Regarding claim 23, wherein the second lumen comprises a first cross- sectional area delimited by side walls of the second lumen, wherein the first cross-sectional area is smaller than any other cross-sectional area of the second lumen delimited by the side walls of the second lumen which faces or is arranged further towards the interior of the port or of the medical treatment apparatus than the first cross-sectional area (fig 3).
Regarding claim 24, wherein the second lumen comprises, in at least one cross-section, no circular cross-sectional area (cross-section taken longitudinally and shown in fig 1).
Regarding claim 25, wherein the first lumen ends in a funnel-shaped or diverging shape in the first end-side opening (fig 3).
Regarding claim 26, wherein the second lumen comprises at least one cross-sectional area which is smaller in its transverse direction than in its height (fig 1, device is elongated).
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.
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al (US 6,296,621).
Regarding claims 27 and 28, wherein a radially outer limitation of the first fluid guide is spaced or distanced, over the entire length of the first fluid guide, or at least in sections, at least 5 or 8 mm from a radially inner surface of the side wall of the second lumen.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine an appropriate gap between the first fluid guide and radially inner surface of the side wall of the second lumen, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claim(s) 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al (US 6,296,621) in view of Pierce et al (US 3,890,968).
Regarding claims 29-32, while Masuda substantially discloses the invention as claimed, it does not disclose a leak sensor, wherein the leak sensor comprises a conductivity sensor, wherein the leak sensor protrudes into the second lumen, nor wherein the leak sensor comprises a pin or ring.
Pierce disclose a leak sensor in the form of a drop detector, wherein the leak sensor comprises a conductivity sensor (Col.6 ll 30-39), wherein the leak sensor protrudes into the second lumen (fig 2, electrodes extend from end of first fluid guide), nor wherein the leak sensor comprises a pin or ring 34 (fig 2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Masuda such that it includes a leak sensor, wherein the leak sensor comprises a conductivity sensor, wherein the leak sensor protrudes into the second lumen, and wherein the leak sensor comprises a pin or ring as taught by Pierce to count the drop rate and thus ensure an appropriate flow rate.
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al (US 6,296,621) in view of Paradis et al (US 4,615,693).
Regarding claims 33 and 34, while Masuda substantially discloses the invention as claimed, it does not disclose wherein the second lumen comprises a recess which in at least one section or cut, comprises a section with a triangular or wedge-shaped shape, nor an inner surface of the side wall of the second lumen comprises the recess.
Paradis discloses a port where the second lumen comprises a recess (fig 3A, recess is in 231 and in which 23a is seated; see circled section in annotated figure below) which in at least one section or cut, which section neither is a longitudinal cut nor extends parallel to a cross-section through the second lumen, comprises a section with a triangular or wedge-shaped shape (wedge shaped), and an inner surface of the side wall of the second lumen comprises the recess (fig 3A). This allows for seating of a disk and diaphragm (fig 3a) which cuts off flow when there is too little fluid (Col.1 ll 51-65) to prevent air from entering patient (Col.1 ll 24-29).
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It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Masuda such that the second lumen comprises a recess which in at least one section or cut, comprises a section with a triangular or wedge-shaped shape, and an inner surface of the side wall of the second lumen comprises the recess as taught by Paradis as it is a known attachment means for two structures which allows for a fitting with greater contact area to better secure said structures together.
Response to Arguments
Applicant's arguments are not persuasive.
Applicant argues Masuda describes an IV set and all the lines described are assigned to an exterior of the medical treatment apparatus. However, Applicant only claims the lines of the medical treatment apparatus as intended use. Applicant has not recited any structures as part of the claimed port to differentiate from the prior art.
Applicant argues the second fluid guide does not comprise an entry point configured to be connected to an air source and a drain configured to be connected to a discharge line of the medical treatment apparatus. Yet applicant has not claimed enough structure to differentiate over Masuda. Masuda has an opening at the top, in which the first fluid guide is situated, but Applicant only claims “an entry point” which is a very broad structure and can simply be an opening, like in Masuda. Said opening may indirectly connected to an air source (and is thus configured to be connected to an air source). Similarly, a drain is a very broad structure and can be an opening, a connector, etc.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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