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 § 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 5 and 14 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.
Claim 5 recites “the exterior wall comprises, a frustoconical shape and a shelf disposed in
between the generally tubular portion and the frustoconical shape, wherein the shelf is
generally parallel to and opposite the seat, wherein the frustoconical shape is proximate
and distal to the shelf and the seat.” The term “the generally tubular portion” lacks
antecedent basis because no generally tubular portion is previously introduced in claim 5
or claim 1.
Claim 14 recites “the exterior wall comprises, a frustoconical shape and a shelf disposed
in between the generally tubular portion and the frustoconical shape, wherein the shelf is
generally parallel to and opposite the seat, wherein the frustoconical shape is proximate
and distal to the shelf and the seat.” The term “the generally tubular portion” lacks
antecedent basis because no generally tubular portion is previously introduced in claim 14
or claim 9.
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.
Claims 1, 4, 7, 8, 9, 10, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Kraus et al. (US 5,902,281; hereinafter “Kraus”) and Burke et al. (US 3,722,697; hereinafter “Burke”).
In relation to claim 1, specifically the limitations:
“an exterior wall shaped to at least partially define a drip chamber that receives a
liquid from a liquid source”.
Jess discloses an IV drip-chamber system having a chamber, an inlet, an outlet, and a liquid source. Specifically, Jess discloses: “The concepts of the present invention reside in a drip chamber for use as part of an intravenous administration set which includes an air blocking, hydrophilic filter element within the drip chamber. The drip chamber generally includes a cylindrical housing provided with inlet means at its upper portion and outlet means at its lower portion.” (Jess col. 2, ll. 34–40.) Jess also discloses: “the sets include a source 72 of the liquid to be administered which is connected by appropriate tubing means 74 to the drip chamber 76.” (Jess col. 5, ll. 44–47.)
“an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores”.
Jess discloses the wet hydrophilic filter’s liquid-passing and air-blocking operation. Specifically, Jess discloses: “Such hydrophilic filter elements have a pore size ranging from about 0.1 μm to about 14 μm; and hydrophilic surface characteristics such that the filter element is wetted by liquid.” (Jess col. 2, ll. 61–64.) Jess further discloses: “Once wetted with liquid, the hydrophilic filter element 26 becomes permeable to the liquid (and impermeable to gases such as air).” (Jess col. 3, ll. 47–50.)
“the exterior wall comprising a seat” and “an attachment component that secures the attachment surface to the seat, wherein the attachment component is disposed entirely within the exterior wall”.
Jess does not expressly disclose a seat having the claimed inner-wall attachment arrangement or a separate attachment component characterized as entirely within the exterior wall. Kraus fills the seat and inside-the-drip-chamber gap by disclosing: “the annular seat 22 receiving the hydrophilic filter 15 is formed on its inner surface so that the hydrophilic filter 15 will be disposed within the drip chamber 3.” (Kraus col. 4, ll. 2–5.) Kraus further discloses a component that secures the filter at that seat: “After the hydrophilic filter 15 has been applied to the flat annular seat 22 of the bottom wall member 12 (FIG. 4), a heated swaging die (not shown) is applied to the annular lip 23 to turn the lip over onto the outer circumference of the hydrophilic filter 15 (FIG. 5), and thereby to secure the hydrophilic filter firmly to the bottom wall member 12.” (Kraus col. 4, ll. 17–22.) To the extent Kraus does not expressly describe the separate ring-and-shoulder attachment arrangement, Burke fills that gap by disclosing: “The filter ring is provided with a tapered portion at the lower part thereof adjacent said recess, and this tapered portion is placed in contact with the annular shoulder formed on the lower wall of the drip chamber. The filter ring is then ultrasonically heated and fused to the annular shoulder at said annular portion of the filter ring so as to connect and seal the filter ring to said shoulder throughout an annular area.” (Burke col. 1, ll. 39–47.)
Motivation to combine. It would have been obvious to combine Jess’s IV drip-chamber and hydrophilic air-blocking filter with Kraus’s inner annular-seat and filter-securing structure, and with Burke’s annular filter-ring/shoulder attachment structure, because each reference addresses a drip chamber having a filter located and retained at a chamber wall. A person of ordinary skill in the art would have been motivated to use the annular seating and securing teachings to retain Jess’s hydrophilic filter inside the drip chamber with a sealed, mechanically stable attachment arrangement.
In relation to claim 4, the rejection of claim 1 is incorporated herein. Additionally, concerning:
“tubing comprising a first end connectable to the drip unit and a second end; and an intravenous access unit connectable to the second end of the tubing to deliver the liquid intravenously to a patient”.
Jess discloses: “The drip chamber 76, in turn, communicates with appropriate tubing 78 terminating in a needle 80 for administration of the liquid to a patient.” (Jess col. 5, ll. 48–50.)
Motivation to combine. It would have been obvious to include the tubing and patient access
arrangement expressly disclosed by Jess in the Jess/Kraus/Burke drip-chamber assembly because Jess identifies that arrangement as the IV administration path for the liquid delivered from the drip chamber to the patient. The predictable result is an IV delivery system that routes liquid from the retained hydrophilic-filter drip chamber to the patient.
In relation to claim 7, the rejection of claim 1 is incorporated herein. Additionally concerning:
“the seat comprises a ridge on which the attachment surface rests”.
The Jess/Kraus combination does not expressly disclose a ridge on which the attachment surface rests. Burke fills that gap by disclosing: “the parts are then assembled in the relationship shown in FIG. 2 with the sharp edge 68 of the filter ring resting on annular shoulder 40 defined on the lower wall of the drip chamber.” (Burke col. 2, ll. 62–67.)
Motivation to combine. It would have been obvious to use Burke’s annular shoulder/edge-rest arrangement in the Jess/Kraus combination because Burke’s arrangement positions the filter ring at a drip-chamber lower wall before attachment. A person of ordinary skill in the art would have been motivated to employ the shoulder as a locating and support feature for the filter-attaching structure to obtain repeatable placement before securing the filter.
In relation to claim 8, the rejections of claims 1 and 7 are incorporated herein. Additionally, concerning:
“the attachment surface comprises ultrasonic welding to the ridge of the seat”.
The Jess/Kraus combination does not expressly disclose ultrasonic welding at the ridge/seat.
Burke fills that gap by disclosing: “The components are then placed within a suitable
ultrasonic heating device 74 which is adapted to ultrasonically heat the components. When
the filter ring is ultrasonically heated, the ultrasonic energy will be concentrated at the
sharp edge 68, thereby causing this portion of the filter ring to be fused to the adjacent
portion of the annular shoulder formed at the bottom of the drip chamber.” (Burke col. 2,
l. 66 to col. 3, I. 6.)
Motivation to combine. It would have been obvious to employ Burke’s ultrasonic-fusion
technique at the locating shoulder of the Jess/Kraus/Burke arrangement because Burke
teaches that the energy concentrates at the ring edge to fuse that portion to the annular
shoulder. The predictable result is a sealed attachment of the filter-attaching structure at
the drip-chamber seat.
In relation to claim 9, specifically the limitations:
“providing an exterior wall shaped to at least partially define a drip chamber” and “providing an anti-run-dry membrane … formed of a hydrophilic material configured to resist passage of air”.
Kraus discloses a drip chamber with a hydrophilic filter that blocks air. Specifically, Kraus discloses: “a housing defining a chamber to be located in a vertical position and including an inlet at the top and an outlet at the bottom; a first hydrophilic filter covering the outlet effective, when wet, to permit the flow therethrough of a liquid and to block the flow therethrough of air.” (Kraus col. 1, ll. 26–35.)
“providing an attachment component disposed entirely within the exterior wall; and positioning the attachment component to abut the anti-run-dry membrane; and securing the attachment component to the seat of the exterior wall”.
Kraus discloses the manufacturing arrangement: “producing a bottom wall member including a circular wall integrally formed with a cylindrical skirt circumscribing the circular wall and formed
with an annular seat around the cylindrical skirt at one side of the circular wall … securing a filter to the annular seat; and bonding the bottom wall member with the filter secured thereto to the open end of the cylindrical wall with the filter disposed within the cylindrical wall.” (Kraus col. 2, ll. 6–15.) Kraus does not expressly identify a separate attachment component that abuts the membrane. Burke fills that gap by disclosing: “The filter ring is provided with a tapered portion at the lower part thereof adjacent said recess, and this tapered portion is placed in contact with the annular shoulder formed on the lower wall of the drip chamber.” (Burke col. 1, ll. 39–42.) Burke further discloses: “The filter ring is then ultrasonically heated and fused to the annular shoulder at said annular portion of the filter ring so as to connect and seal the filter ring to said shoulder throughout an annular area.” (Burke col. 1, ll. 43–46.)
Motivation to combine. It would have been obvious to combine Kraus’s method of manufacturing a drip chamber with an annular seat and a hydrophilic filter with Burke’s separate filter-ring attachment technique because both references describe assembling a filter at an annular drip-chamber seat or shoulder. A person of ordinary skill in the art would have been motivated to use Burke’s ring as the attachment component in Kraus’s manufacturing process to provide a defined component that abuts and seals the filter at the seat.
In relation to claim 10, the use of a pressure-sensitive adhesive (PSA) is a well-known and common type of adhesive in the medical device field. The specification of the present application itself acknowledges this, stating, "The adhesive ring 912 may be formed of a pressure- sensitive adhesive" (para. [0093]-[0094]). Thus, in response to compression of the adhesive ring, the adhesive ring may adhere to the seat and to the attachment surface of the anti-run-dry membrane. This is an admission that using a PSA secured by compression is a known and conventional method. Therefore, it would have been an obvious matter of design choice for one of ordinary skill in the art to select a pressure-sensitive adhesive from the known types of adhesives for use in the system resulting from the combination of the cited prior art references. The motivation would be to use a clean, easy-to apply, and reliable adhesive that requires no curing time, which are known advantages of PSAs. Securing a PSA via compression is the inherent and standard method of activating its adhesive properties.
In relation to claim 13, the rejection of claim 9 is incorporated herein. Additionally, concerning:
“providing tubing … and providing an intravenous access unit … to deliver the liquid intravenously to a patient”.
The Kraus/Burke combination does not expressly disclose the full claimed tubing/access-unit wording. Jess fills that gap by disclosing: “The drip chamber 76, in turn, communicates with appropriate tubing 78 terminating in a needle 80 for administration of the liquid to a patient.” (Jess col. 5, ll. 48–50.)
Motivation to combine. It would have been obvious to include Jess’s tubing-and-needle administration path in the manufactured Kraus/Burke drip-chamber system because Jess expressly identifies the path from the drip chamber through tubing to a needle for administration to a patient. The predictable result is a manufactured IV delivery system that is configured to deliver the liquid to the patient.
In relation to claim 16, the rejection of claim 9 is incorporated herein. Additionally, concerning:
“the seat comprises a ridge on which the attachment surface rests”.
Kraus does not expressly disclose the claimed ridge-rest arrangement. Burke fills that gap by disclosing: “the sharp edge 68 of the filter ring resting on annular shoulder 40 defined on the lower wall of the drip chamber.” (Burke col. 2, ll. 64-66.)
Motivation to combine. It would have been obvious to use Burke’s annular shoulder and filter-ring edge-rest arrangement in Kraus’s manufacturing process because Burke teaches that the parts are assembled with the filter-ring edge resting on the annular shoulder before ultrasonic attachment. A person of ordinary skill in the art would have been motivated to use this locating relationship to position the filter-attaching structure at the seat during manufacture.
In relation to claim 17, the rejections of claims 9 and 16 are incorporated herein. Additionally, concerning:
“the attachment surface comprises ultrasonic welding to the ridge of the seat”.
Kraus does not expressly disclose ultrasonic welding at the ridge/seat. Burke fills that gap by
disclosing: “The components are then placed within a suitable ultrasonic heating device
74 which is adapted to ultrasonically heat the components. When the filter ring is ultrasonically heated, the ultrasonic energy will be concentrated at the sharp edge 68, thereby causing this portion of the filter ring to be fused to the adjacent portion of the annular shoulder formed at the bottom of the drip chamber.” (Burke col.2, starting in line 66.)
Motivation to combine. It would have been obvious to employ Burke’s ultrasonic-fusion
technique in Kraus’s seat-based manufacturing method because Burke teaches fusing the
ring edge to an annular shoulder in a drip chamber. The predictable result is a sealed
attachment at the seat after the filter-attaching structure has been positioned thereon.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Kraus et al. (US 5,902,281; hereinafter “Kraus”) and Burke et al. (US 3,722,697; hereinafter “Burke”), as discussed above, and in further view of Johnsen et al. (US 5,085,652; hereinafter “Johnsen”).
In relation to claim 2, the rejection of claim 1 is incorporated herein. Additionally, concerning:
“the attachment component comprises an adhesive ring disposed on the seat”.
The Jess/Kraus/Burke combination does not expressly disclose an adhesive ring that is pressure-sensitive. Johnsen fills that gap by disclosing: “A substantially annular border member is provided as part of the assembly. The border member is composed of a closed cell foam. It is preferably coplanar with and surrounds the filter disk. Preferably, the border member is coated with a pressure sensitive adhesive layer.” (Johnsen col. 3, ll. 14–18.)
“the seat is generally perpendicular to a longitudinal axis of the drip chamber and comprises an annular surface”.
Kraus discloses the claimed annular surface and its placement at the bottom end of the drip chamber. Specifically, Kraus discloses: “producing a bottom wall member including a circular wall integrally formed with a cylindrical skirt circumscribing the circular wall and formed with an annular seat around the cylindrical skirt at one side of the circular wall.” (Kraus col. 2, ll. 6–10.) Kraus further discloses: “the annular seat 22 receiving the hydrophilic filter 15 is formed on its inner surface.” (Kraus col. 4, ll. 2–4.)
Motivation to combine. It would have been obvious to apply Johnsen’s annular, pressure-sensitive adhesive border to the annular seating arrangement of the Jess/Kraus/Burke combination because Johnsen expressly identifies an annular member coated with a pressure-sensitive adhesive layer for positioning an associated filter. A person of ordinary skill in the art would have been motivated to select that adhesive-ring attachment technique as an alternative to a permanent mechanical or welded attachment where an annular filter-support interface is already present.
In relation to claim 3, the use of a pressure-sensitive adhesive (PSA) is a well-known and common type of adhesive in the medical device field. The specification of the present application itself acknowledges this, stating, "The adhesive ring 912 may be formed of a pressure-sensitive adhesive" (para. [0093]-[0094]). Thus, in response to compression of the adhesive ring, the adhesive ring may adhere to the seat and to the attachment surface of the anti-run-dry membrane. This is an admission that using a PSA secured by compression is a known and conventional method. Therefore, it would have been an obvious matter of design choice for one of ordinary skill in the art to select a pressure-sensitive adhesive from the known types of adhesives for use in the system resulting from the combination of the cited prior art references. The motivation would be to use a clean, easy-to apply, and reliable adhesive that requires no curing time, which are known advantages of PSAs. Securing a PSA via compression is the inherent and standard method of activating its adhesive properties.
Allowable Subject Matter
Claims 5, 6, 11, 12, 14, and 15 are 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 a statement of reasons for the indication of allowable subject matter:
In relation to claims 5 and 6, the prior art of record does not disclose or suggest, inter alia, wherein the exterior wall comprises a frustoconical shape and a shelf disposed in between the generally tubular portion and the frustoconical shape, wherein the shelf is generally parallel to and opposite the seat, wherein the frustoconical shape is proximate and distal to the shelf and the seat.
In relation to claim 11, the prior art of record does not disclose or suggest, inter alia, wherein the exterior wall comprises a plurality of interference features that protrude inward; wherein positioning the attachment component to abut the anti-run-dry membrane comprises contacting an outer edge of the anti-run-dry membrane with the interference features such that the interference features provide radial interference with the outer edge, the radial interference tending to retain the anti-run-dry membrane relative to the exterior wall.
In relation to claim 12, the prior art of record does not disclose or suggest, inter alia, wherein the anti-run-dry membrane comprises a plurality of interference features that protrude outward; wherein positioning the attachment component to abut the anti-run-dry membrane comprises contacting an interior surface of the exterior wall with the interference features such that the interference features provide radial interference with the interior surface, the radial interference tending to retain the anti-run-dry membrane relative to the exterior wall.
In relation to claims 14 and 15, the prior art of record does not disclose or suggest, inter alia, wherein the exterior wall comprises a generally tubular portion, a frustoconical shape, and a shelf disposed in between the generally tubular portion and the frustoconical shape.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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