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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 6, 7, 9, 12, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8,991,876 to Lauer in view of U.S. Patent No. 5,755,696 to Caizza, and alternatively further in view of U.S. Patent Publication No. 2021/0404587 to Mansour et al. (“Mansour”).
Regarding claim 1, Lauer discloses a disposable (as indicated in annotated Fig. 28 below) comprising a fluid line (as indicated in annotated Fig. 28 below) and a connector (as indicated in annotated Fig. 28 below) of the fluid line, wherein the connector includes a connector lumen (as indicated in annotated Fig. 28) that capable of fluidically connecting the fluid line with a first lumen of a first fluid guide of a port (see annotated Fig. 28 below), wherein the connector comprises a touch-protection cover (see annotated Fig. 28 below) with one end defining a free connection opening (opening formed by bottom of the cover in Fig. 28), wherein inside the touch-protection cover, the connector lumen is surrounded by a wall (wall formed around connector lumen) defining an opening (opening formed by bottom of the wall), but does not explicitly disclose the free connection opening and the opening defined by the wall having a minimum distance of at least 5 mm from each other and the rib structure.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device taught by Lauer to have a minimum distance of at least 5 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed 5 mm distance, as this distance would be suitable for allow for sufficient and efficient fluid flow in the space between the free connection opening and the opening of the wall.
Caizza teaches a rib structure comprising a plurality of ribs (Fig. 2, ribs emanating from 33), at least a first rib of the plurality of ribs extending in a longitudinal direction of the connector (Fig. 2) and terminating at a point that is at or before the free connection opening (43, Fig. 2), wherein at least the first rib has an outward facing surface with a substantially straight profile (Fig. 2, all the ribs are substantially straight). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rib structure of Caizza onto the touch-protection cover of Lauer in order to provide frictional engagement with a mating element ([0059]).
Once combined, the rib structure of Lauer and Caizza would be capable of being arranged to be introduced at least in sections into a second lumen of the port (as the connector is lowered into a port, the ribs would naturally be introduced in sections) when the connector is connected to the medical treatment apparatus.
Regarding the second rib, it is noted that a mere change in form or shape, without any new or unexpected results, is an obvious engineering design (MPEP § 2144.04). Since applicant has not disclosed that having one shorter rib (i.e., not terminating at free connection opening) does anything more than produce predictable results (i.e., providing grip variation), the mere shortening of one rib is not considered to have patentable significance. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify the rib structure of Lauer and Caizza to include a second rib which terminates at a point that is not at the free connection opening, in order to predictably provide grip variation.
Alternatively, Mansour teaches first and second ribs extending to differing lengths (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one of the ribs of Lauer and Caizza to not extend as far as another rib as taught by Mansour to yield the predictable result of providing grip variation.
Regarding claim 2, Lauer and Caizza, and alternatively Mansour teach the disposable as claimed in claim 1, but do not teach the free connection opening and the opening defined by the wall have a minimum distance of at least 10 mm from each other.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device taught by Lauer to have a minimum distance of at least 10 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed 10 mm distance, as this distance would be suitable for allow for sufficient and efficient fluid flow in the space between the free connection opening and the opening of the wall.
Regarding claim 4, Lauer and Caizza, and alternatively Mansour teach the disposable according to claim 1 as shown above, Caizza further teaches ear pair of two adjacent ribs of the plurality of ribs, both terminating at a point that is at the free connection opening (Fig. 2, all the ribs of Caizza extend to the end of the analogous connector structure) which delimit recesses (recesses formed between adjacent ribs) that are arranged between the adjacent ribs, but does not explicitly disclose the depths of the recesses being between 5% and 15% of the cross-section of the connector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the depth of the recesses as taught by Ryan to be 5% to 15% of the cross-section of the connector, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Ryan would not operate differently with the claimed depths being between 5% to 15% of the cross-section area of the connector, as these relative depths would be suitable for allow for proper fitment of the connector into the port.
Regarding claim 6, Lauer and Caizza, and alternatively Mansour teach the disposable according to claim 1, Caiza further teaching the first rib extends from a second end of the touch-protection cover (portion of the touch-protection cover at the disc structure of Lauer as shown above) opposite the one end defining the free connection opening and terminates at the point that is at or before the free connection opening (Fig. 2, the ribs are formed along the entire length of associated portion of the blunt cannula assembly 33, once combined with Lauer, the ribs would extend along the entire length of the touch-protection cover).
Regarding claim 7, Lauer and Caizza, and alternatively Mansour teach the disposable according to claim 1 as shown above, Caizza further teaches the plurality of ribs (Fig. 2) but does not specify sixteen ribs. However, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have used 16 ribs distributed over the circumference of the touch-protection cover of the device of Lauer and Caizza, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 9, Lauer teaches a disposable (as indicated in annotated Fig. 28 above) and a port (100), wherein the disposable comprises a fluid line (as indicated in annotated Fig. 28 above) and a connector (as indicated in annotated Fig. 28 above) of the fluid line of the disposable, wherein the connector includes a connector lumen (as indicated in annotated Fig. 28 above) for fluidically connecting the fluid line of the disposable with a first lumen (lumen of the 1st fluid guide in annotated Fig. 28 above) of a first fluid guide of the port (1st fluid guide in annotated Fig. 28 above), wherein the port is configured to establish fluid communication, via the first fluid guide of the port, with fluid within an interior of a medical treatment apparatus (it is noted that the medical treatment apparatus is not positively recited and that the port is capable of establishing fluid communication with a medical treatment apparatus and/or an interior thereof), the connector comprises a touch-protection cover (as indicated in annotated Fig. 28 above) with one end defining a free connection opening (bottom of touch-protection cover), wherein inside the touch-protection cover the connector lumen is surrounded by a wall (wall formed around connector lumen) defining an opening (opening formed by bottom of the connector lumen), the port (100) of the medical treatment apparatus is configured to establish a fluid communication with at least one fluid line of the medical treatment apparatus wherein the at least one fluid line of the medical treatment apparatus is assigned to the interior of the medical treatment apparatus and the connector lumen of the fluid line of the disposable, wherein the fluid line of the disposable is assigned to an exterior of the medical treatment apparatus (it is noted that the medical treatment apparatus is not positively recited and that the port is capable of establishing fluid communication with at least one fluid line of a medical treatment apparatus that is assigned to the interior of the medical treatment apparatus and the connector lumen and the fluid line of the disposable is capable of being assigned to an exterior of a medical treatment apparatus), the first fluid guide of the port comprising at least the first lumen (as previously identified) and a first end-side opening (opening at top of the first fluid guide as previously identified) the first fluid guide being provided for receiving and/or guiding a medical fluid and/or for establishing fluid communication with the connector (700), the port comprising a second fluid guide (see annotated Fig. 28 above) having at least the second lumen (lumen formed by second fluid guide as previously identified) and a second end-side opening (opening at top of the second fluid guide as previously identified), and the first end-side opening of the first fluid guide is arranged at least partially in the second lumen of the second fluid guide (longitudinal sections of the lumen of the first fluid guide as previously identified are positioned within the second lumen of the second fluid guide as previously identified, see annotated Fig. 28 above), but does not explicitly disclose the free connection opening and the opening of the wall having a minimum distance of at least 5 mm from each other and the rib structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device taught by Lauer to have a minimum distance of at least 5 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed 5 mm distance, as this distance would be suitable for allow for sufficient and efficient fluid flow in the space between the free connection opening and the opening of the wall.
Caizza teaches a rib structure comprising a plurality of ribs (Fig. 2, ribs emanating from 33), wherein at least a first rib of the plurality of ribs extends in a longitudinal direction of the connector (Fig. 2) and terminates at a point that is at or before the free connection opening (43, Fig. 2), and wherein at least the first rib has an outward facing surface with a substantially straight profile (Fig. 2, all the ribs are substantially straight). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rib structure of Caizza onto the touch-protection cover of Lauer in order to provide frictional engagement with a mating element ([0059]).
Once combined, the rib structure of Lauer and Caizza would be capable of being arranged to be introduced at least in sections into a second lumen of the port (as the connector is lowered into a port, the ribs would naturally be introduced in sections) when the connector is connected to the medical treatment apparatus.
Regarding the second rib, it is noted that a mere change in form or shape, without any new or unexpected results, is an obvious engineering design (MPEP § 2144.04). Since applicant has not disclosed that having one shorter rib (i.e., not terminating at free connection opening) does anything more than produce predictable results (i.e., providing grip variation), the mere shortening of one rib is not considered to have patentable significance. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify the rib structure of Lauer and Caizza to include a second rib which terminates at a point that is not at the free connection opening, in order to predictably provide grip variation.
Alternatively, Mansour teaches first and second ribs extending to differing lengths (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least one of the ribs of Lauer and Caizza to not extend as far as another rib as taught by Mansour to yield the predictable result of providing grip variation.
Regarding claim 12, Lauer and Caizza, and alternatively Mansour teach the system according to claim 9 as shown above, Lauer further teaches an edge (top of the first fluid guide as previously identified) delimiting the first end-side opening is spaced from an inner wall of the second lumen at an inherent distance (distance between the edge and inside of the second fluid guide as previously identified), but fails to explicitly mention that the distance is greater than or equal to 5 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device taught by Lauer to have a distance of greater than or equal to 5 mm between the first end-side opening and the inner wall of the second lumen, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed 5 mm minimum distance, as this distance would be suitable for allow for sufficient fluid flow or fitment between the port and the disposable.
Regarding claim 13, Lauer and Caizza, and alternatively Mansour teach the system according to claim 13 as shown above, Lauer further teaches that a length of the touch-protection cover is determined such that a front side or surface of the touch-protection cover surrounding the free connection opening is guided through an inner wall of the second end-side opening or adjacent to the second lumen of the port during insertion of the connector into the second lumen of the port in such a way that the touch-protection cover does not come into contact with the first fluid guide (as can be seen in annotated Fig. 28 above, the length of the touch-protection cover has sufficient length such that the opening of touch-protection cover does not touch the first fluid guide upon insertion).
Regarding claim 15, Lauer and Caizza, and alternatively Mansour teach the system according to claim 9 as shown above, Lauer further teaches a length of the touch-protection cover being set such that a front side of the opening of the connector lumen cannot come into contact with the first fluid guide during insertion of the connector into the second lumen of the port (the length of the touch-protection cover provides a sufficient distance between the lowest end of the touch-protection cover and the lowest end of the connector, such that upon initial insertion of the disposable 200 into the port 100, the connector lumen does not touch the first fluid guide).
Regarding claim 16, Lauer and Caizza, and alternatively Mansour teach the system according to claim 9 as shown above, Lauer further teaches a medical treatment apparatus (300, Figs. 5-6), the medical treatment apparatus comprising a housing (housing of 300) with a fastening section for connecting the medical treatment apparatus to the port (as seen in at least Fig. 5, port 100 is positioned within the medical treatment apparatus, the fastening section being any portion of the medical treatment apparatus contacting the port such as element 49 in Fig. 3).
Regarding claim 17, Lauer and Caizza, and alternatively Mansour teach the system according to claim 16 as shown above, Lauer further teaches the fastening section comprising an edge (edge formed by inner portions of 49, see annotated Fig. 3 below), wherein the edge extends in a first section (top part of the edge as shown in annotated Fig. 3 below) annularly with an inner radius (annular inner radius the first section), wherein a second section of the edge is not part of the annular shape having the inner radius and being formed by the first section (bottom of the edge that is flared outward as shown in annotated Fig. 3 below is separate from the inner radius of the first section).
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Regarding claim 18, Lauer and Caizza, and alternatively Mansour teach the system according to claim 17 as shown above, Lauer further teaches the disc structure being round (Fig. 28) but is silent as to a distance between an outer edge section or the outer radius of the disc structure and the first section of the edge, and does not specifically disclose at most 1 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lauer to have a spacing of at most 1 mm between the disc structure and the first section of the edge, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed at most 1 mm spacing, as this length range would be suitable to allow for sufficient clearance and fitment as a disc structure of the disposable is mounted to the medical treatment apparatus.
Regarding claim 19, Lauer and Caizza, and alternatively Mansour teach the system according to claim 18 as shown above, Lauer further teaches the system according to claim 18, but is silent as to the distance between the outer edge section or the outer radius of the disc structure and the second section of the edge, and does not specifically disclose at least 3 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lauer to have a spacing of at least 3 mm between the disc structure and the second section of the edge, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the device of Lauer would not operate differently with the claimed at least 3 mm spacing, as this length range would be suitable to allow for sufficient clearance and fitment as a disposable is mounted to the medical treatment apparatus.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lauer and Caizza, and alternatively Mansour as applied to claim 1 above, and further in view of U.S. Patent No. 11,890,446 to Harandi et al. (“Harandi”).
Regarding claim 5, Lauer and Caizza, and alternatively Mansour teach the disposable according to claim 1 as shown above, but do not teach the ribs having different lengths.
Harandi teaches two of a plurality of ribs have different lengths (Figs. 12A-12B) as an alternative to two of a plurality of ribs having the same length (Fig. 2A). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the equal length ribs of Caizza with an alternative rib configuration where at least two ribs have different lengths as taught by Harandi, since such a modification would be considered a simple substitution of one known rib configuration for another to obtain the predictable result of providing friction for engagement.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lauer and Caizza, and alternatively Mansour as applied to claim 1 above, and further in view of U.S. Patent No. 9,884,176 to Fangrow.
Regarding claim 8, Lauer and Caizza, and alternatively Mansour teach the disposable according to claim 1 as shown above, Lauer further teaching the connector comprises at least a disc structure (see annotated Fig. 28 above) but fails to teach a drip disc and ribs. Fangrow teaches a disc structure (60a or 60b or 60c in Fig. 2) and ribs (62 in Fig. 2) in a similar type of medical connector.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the disc structure (60a or 60b or 60c) and ribs (62) of Fangrow into the device of Lauer in order to provide better fitment of the connector into the port (column 11, lines 54-58). Once combined, the ribs would be arranged between the drip disc and the disc structure in the modified device of Lauer. Additionally, once combined, the ribs of the modified Lauer device would extend at an angle between 75° and 105° (specifically 90° or orthogonal) to a flow-through lumen of the connector (the ribs extend perpendicularly to the longitudinal axis of the connector, which is where the lumen in Lauer is positioned).
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lauer and Caizza, and alternatively Mansour as applied to claim 9 above, and further in view of U.S. Patent Publication No. 2018/0021561 to Nelson et al. (“Nelson”).
Regarding claim 10, Lauer and Caizza, and alternatively Mansour teach the system according to claim 9 as shown above, but fail to explicitly disclose the second end-side opening of the second fluid guide having smaller cross-sectional area than the cross-sectional area of the second fluid guide further inward.
Nelson teaches a second end-side opening (opening at top of 128 or Cross-sectional area 1 in annotated Fig. 14 below) of a second fluid guide of a port (120) having a cross-sectional area smaller than a cross-sectional area of the second lumen arranged farther towards the interior (Cross-sectional area 2 in annotated Fig. 14 below) than the second end-side opening (Cross-sectional area 2 is larger than that of Cross-sectional area 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a port design incorporating a smaller cross-sectional area in an opening than the cross-section further in the interior of the port of Lauer as taught by Nelson, because such port designs are old and well-known in the art for the purpose of accommodating different types of disposable tip shapes that are being inserted therein and to provide adequate space for clearance of the disposable once inserted and/or sufficient space for fluid flow. Once combined, the cross-sectional area of the opening would be smaller than the cross-sectional area of the second lumen arranged farther towards the interior of the treatment apparatus than the second end-side opening.
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Regarding claim 14, Lauer and Caizza teach the system according to claim 9, but fail to explicitly disclose the increasing of the cross-sectional area of the second lumen.
Nelson teaches a cross-sectional area of a second lumen (lumen of 100) of the port increases continuously and/or steadily in an axial direction up to the beginning of an opening of the port (bottom of 100) which radially widens the second lumen in at least one cross-section (the cross-sectional area of the lumen increases from the Plane of the first end-side opening to the Cross-sectional area 2 of in annotated Fig. 14 above).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a port design incorporating an increasing cross-sectional area starting from an opening plane of a first end-side opening of a first lumen into the port of Lauer as taught by Nelson, because such port designs are old and well-known in the art for the purpose of accommodating different types of disposable tip shapes that are being inserted therein and to provide adequate space for clearance of the disposable once inserted and/or sufficient space for fluid flow.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lauer and Caizza, and alternatively Mansour as applied to claim 9 above, and further in view of U.S. Patent Publication No. 2018/0008812 to Roxas et al. (“Roxas”).
Regarding claim 11, Lauer and Caizza, and alternatively Mansour teach the system according claim 9 as shown above, but do not explicitly teach the first lumen of the port having a diverging shape.
In at least Fig. 5, Roxas teaches a first lumen (54) of a port (52) ending in a diverging shape in the first end-side opening (left opening of 52) in a similar type of medical connector. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a diverging shape for the lumen of the port of Lauer as taught by Roxas, because such port designs are old and well-known in the art for the purpose of providing a smoother transition during insertion of an associated disposable therein and to provide adequate fitment of the disposable upon attachment.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lauer and Caizza, and alternatively Mansour as applied to claim 16 above, and further in view of U.S. Patent Publication No. 2014/0031754 to Williams et al. (“Williams”).
Regarding claim 20, Lauer and Caizza, and alternatively Mansour teach the system according to claim 16 including the medical treatment apparatus as shown above, but do not teach the swivel lever.
Williams teaches a swivel lever (54, Fig. 5), arranged for pivoting about a swivel axis (axis shown in Fig. 5), wherein the swivel lever comprises a stop (72) to temporarily prevent an axial separation movement for separating the connector (58) of the disposable from a fastening section (50) by or after pivoting the swivel lever into a second pivot position of the swivel lever (74), wherein the stop is designed to limit rotation of the inserted connector about the longitudinal axis of its connector lumen (rotation and axial separation are limited once in the locked configuration) in similar medical connector system.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the swivel lever of Williams into the device of Lauer in order to advantageously provided a rigid attachment between the disposable and the medical treatment apparatus to prevent unwanted or unintentional separation during a medical procedure.
Response to Arguments
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lauer, Caizza, and alternatively Mansour as shown above.
In order to move prosecution forward, Examiner suggests incorporating language pertaining to the dent or indentation 2009 which is not covered by the disc structure as described in paragraphs [0196] and [0198] of the pending application U.S. Patent Publication No. 2022/0105335.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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