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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
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 one 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 the at least one of the plurality of ribs 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 claim 2, Lauer and Caizza 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 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 teach the disposable according to claim 1, Caiza further teaching the at least one of the plurality of ribs 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 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 one 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 the at least one of the plurality of ribs 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 claim 12, Lauer and Caizza 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
The specification amendments were received on 09/02/2025. These specification amendments are acceptable.
The drawings were received on 09/02/2025. These drawings are acceptable.
Applicant’s argument and amendments, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to the claim objection has been fully considered and are persuasive. The claim objection has been withdrawn.
Applicant’s arguments and amendments with respect to the 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments and amendments filed 09/02/2025 regarding the art rejections have been fully considered and are not persuasive. Applicant argues, inter alia, that the modification to add the ribs of Caizza onto the touch-protection cover of Lauer would render Lauer’s device non-functional for its intended purpose. Examiner respectfully disagrees.
Examiner submits that the majority of recitations from the Caizza reference pertain to different embodiments and not directly speak to the embodiment of Fig. 28 and improperly import limitations from other embodiments into the embodiment relied upon for the rejection. In any case, Applicant’s recitation of column 10 of Caizza about the smooth axial displacement of an inner pipe within an outer pipe refer to the interaction between the connector lumen and 1st fluid guide (in annotated Fig. 28 above) and would not be affected by adding ribs to the touch-protection cover. Regarding Applicant’s recitation of columns 14, 15, and 1 of Caizza regarding the widening of the inner pipe to expand against a connection pipe again refers to the inner pipes and are not affected by adding ribs to the touch-protection cover. Regarding Applicant’s reference to “sealing ring zones” from column 15 of Caizza, the relied upon embodiment of Fig. 28 has no annular sealing bars or elastic rings.
Pertaining to the embodiment of Fig. 28 of Caizza, Applicant’s reference to columns 30-31 concerning the smooth design and effective classical touch protection again pertain to the “intermediary of retracted connection-relevant inner connectors (inner pipe and connection pipe)” [emphasis added] or inner pipes and are not affected by adding ribs to the touch protection cover or the interaction of the outer pipes.
Applicant also references column 30 lines 62+ which states “[s]uch an arrangement is particularly used for applications in which a connection is achieved manually and/or pre-centering is achieved directing through the intermediary of the connector assemblies and/or additional means for lateral tolerance compensation are omitted…” Examiner submits there is no indication that pre-centering is necessarily achieved without additional means for lateral tolerance or that pre-centering requires the absence of additional means of lateral tolerance; each statement stands on its own and each statement is further in the alternative. The pre-centering in lines 64-65 relies upon the “intermediary of the connector assemblies” which appear to be referring to the inner pipes as somewhat defined in column 31, lines 11-13. In any case, the language itself does not explicitly refer to the outer pipes being relied upon for pre-centering and does not exclude the use of structure that may aid in pre-centering of the outer pipes. Additionally, the omission of additional means for lateral tolerance in lines 65-66 is in the alternative so it is not required for the previous statement about pre-centering. Furthermore, it appears that the types of structures used in other embodiments in Caizza for improving lateral tolerances again pertain to the inner pipes so any possible exclusion of lateral tolerance compensation is non-analogous to adding ribs to the outer pipe of the disposable or the touch-protection cover which pertain to the outer pipes.
Applicant further argues that “[i]ntroducing these localized, interrupting ribs of Caizza onto Lauer’s device… would fundamentally disrupt Lauer’s axial sealing structure and render Lauer’s device inoperable by rendering ineffective the fluid seal of Lauer’s device. Examiner respectfully disagrees. The fluid seal in question, as emphasized throughout Caizza, is between the inner connectors, namely, the inner pipe and the connection pipe, not the outer pipes, and the addition of ribs on the touch-protection cover would not affect the seal between the inner connectors. As previously noted, the omission of additional lateral tolerance compensation is optional and therefore not required for pre-centering due to the alternative language, and any intended potentially omitted structure related to lateral tolerances, as understood in alternative embodiments of Caizza, is unrelated to the outer pipes. It is noted that Caizza is silent pertaining to any seal pertaining to the outer pipes for Fig. 28. The rejection stands.
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
THIS ACTION IS MADE FINAL. 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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783