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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 19-34) in the reply filed on 12/10/2025 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 33 and 34 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.
In claim 33, Applicant requires “which section neither is a longitudinal cut nor extends parallel to a cross-section through the second lumen”. The examiner does not understand how this can be. A recess in a three dimensional object is going to extend along at least a bit of the longitude of the device and radially (parallel to a cross-section through the second lumen). It is assumed object 57 in fig 3 is the claimed recess and it can be seen to have components in both dimensions it is claimed not to have.
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), 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, 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, 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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Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783