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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 04/14/2023 and 03/28/2025 has/have been considered by the Examiner.
The information disclosure statement filed 08/30/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, and the information referred to therein has been considered except where lined through. Specifically, no explanation of relevance is provided for CN-111765309-A.
Status of the Claims
Claims 1-20 are currently pending. Claims 1-20 are currently rejected.
Claim Objections
Claims 2 and 12 are objected to because of the following informalities:
Claim 2 line 2 reads “one of a score line, groove, laser cut line, perforation, a thinned portion of a wall of the body”. This should read “one of a score line, groove, laser cut line, perforation, or a thinned portion of a wall of the body”.
Claim 12 line 2 reads “one of a score line, groove, laser cut line, perforation, a thinned portion of a wall of the body”. This should read “one of a score line, groove, laser cut line, perforation, or a thinned portion of a wall of the body”.
Appropriate correction is required.
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 3-9 and 13-19 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 3 recites the limitation “a first tear line and a second tear line” on lines 2-3. Claim 1, from which claim 3 depends, introduces “a tear line” on line 6. It is unclear whether the two tear lines introduced in claim 3 are meant to include the tear line of claim 1 (two total tear lines) or whether claim 3 is meant to introduce two new, different tear lines in addition to the tear line in claim 1 (three total tear lines). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 9 recites the limitation "relative to longitudinal axis" in line 2. There is insufficient antecedent basis for this limitation, “longitudinal axis” in the claim. For the purposes of examination, this limitation is interpreted to read “relative to a longitudinal axis of the body” in line with limitations recited in related claims 5 and 7.
Claim 13 recites the limitation “a first tear line and a second tear line” on lines 2-3. Claim 11, from which claim 13 depends, introduces “a tear line” on line 6. It is unclear whether the two tear lines introduced in claim 13 are meant to include the tear line of claim 11 (two total tear lines) or whether claim 13 is meant to introduce two new, different tear lines in addition to the tear line in claim 11 (three total tear lines). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 19 recites the limitation "relative to longitudinal axis" in line 2. There is insufficient antecedent basis for this limitation, “longitudinal axis” in the claim. For the purposes of examination, this limitation is interpreted to read “relative to a longitudinal axis of the body” in line with the limitations recited in related claims 15 and 17.
Claims 4-9 and 14-19 are rejected at least for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are alternatively rejected under 35 U.S.C. 102(a)(1)/(a)/(2) as being anticipated by Pickhard (US 4720285 A; hereafter Pickhard).
Alternatively, regarding claim 1, Pickhard discloses a peelable cathlock (two-part protective cap 10, fig. 1), comprising:
a body (11 and 12, col. 2 ln. 59-63 “two-part protective cap 10 comprising a securing device 11 and a needle protection cap 12”, fig. 1) defining a cylindrical shape and extending from a first end (needle protection cap 12, fig. 1) to a second end (securing device 11, fig. 1), the body defining a lumen providing fluid communication between the first end and the second end (see hollow space in fig. 1 along length of cathlock/cap 10), the first end (12, fig. 1) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to attach to a proximal end of a catheter (needle carrier 5 and syringe needle 4, figs. 1 and 3) (col. 2 ln. 59-63, “At its end face 9 facing towards the syringe needle 4, the annular flange 6 is joined to a two-part protective cap 10 comprising a securing device 11 and a needle protection cap 12, the joint being obtained by ultrasonic welding.”), and the second end is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to attach to a port stem (attachment member 2, fig. 1) (col. 2 ln. 69-col. 3 ln. 2, “inwardly projecting claws 13 of the securing device 11 of the protective cap 10 acting as a base element, engaging in the annular groove 3”); and
a tear line (score line 14, figs. 1 and 2) extending along a portion of the body and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow the body to separate therealong when a force is applied (col. 3 ln. 8-14, two parts of cathlock/cap 10 break apart at score line 14, see figs. 1 and 2).
Examiner notes that since the cap 10 connects two pieces of medical equipment with lumens, the cap 10 is capable of meeting the noted functional limitations above.
Regarding claim 2, Pickhard discloses the peelable cathlock according to claim 1, including wherein the tear line includes one of a score line (score line 14, fig. 1, col. 3 ln. 8-14, two parts of cathlock/cap 10 break apart at score line 14), groove, laser cut line, perforation, a thinned portion of a wall of the body.
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.
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.
Claim(s) 1-2 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders (US 20050124980 A1; hereafter Sanders) in view of Potter et al (US 20050010238 A1; hereafter Potter).
Regarding claim 1, Sanders discloses a peelable cathlock (locking sleeve 26, fig. 2c, [0042] The locking sleeve 26 may be a cathlock that slides over the length of the catheter 4 and over the barb 18 on the port stem 14 and maintains a compression over the distal section of the catheter 4.), comprising:
a body defining a cylindrical shape and extending from a first end to a second end (see body of cathlock 26 extending between first end and second end noted in annotated Sanders fig. 2c below), the body defining a lumen providing fluid communication between the first end and the second end (see hollow space in fig. 3b along length of cathlock), the first end is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to attach to a proximal end of a catheter (catheter 4, fig. 2c, [0042]), and the second end is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to attach to a port stem (port stem 14, fig. 2c, [0042]) (see annotated fig. 2c below, see also fig. 3b); and
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Sanders is silent to a tear line and removal of the cathlock.
Potter, in the art of catheters, teaches a cathlock (sheath hub 208, fig. 4, [0094]) providing fluid communication ([0094] a fluid-tight seal is formed between the sheath 100 and the sheath hub 208; [0063] describes fluid tight seal between the sheath hub 208 and the cannular portion 200 of the valve housing 90, see fig. 4) between a port stem (valve housing 90, fig. 4, [0063]) and a catheter (sheath 100, fig. 4, [0063]);
a tear line (grooves 230, fig. 1, [0084]) extending along a portion of the body (frustum portion 226 of sheath hub 208, fig. 1, [0084]) and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow the body to separate therealong when a force is applied ([0084] cathlock/sheath hub 208 splits along grooves 230, see fig. 8d) ([0087] sheath hub 208 splits along grooves 230).
Regarding claim 2, Sanders modified by Potter discloses the peelable cathlock according to claim 1, as described above, including wherein the tear line (Potter: grooves 230, fig. 1, [0084]) includes one of a score line, groove (Potter: [0087] sheath hub 208 splits along grooves 230), laser cut line, perforation, a thinned portion of a wall of the body.
Regarding claim 11, Sanders discloses a method of removing a cathlock from a catheter system, comprising:
providing a cathlock (locking sleeve 26, fig. 2c, [0042] The locking sleeve 26 may be a cathlock that slides over the length of the catheter 4 and over the barb 18 on the port stem 14 and maintains a compression over the distal section of the catheter 4.) including a body defining a substantially cylindrical shape and extending from a first end to a second end (see body of cathlock 26 extending between first end and second end noted in annotated Sanders fig. 2c below), and the cathlock (26) providing fluid communication (see fig. 2c and fig. 3b) ([0050] the final assembly will have a good connection between the three parts: access port 2, catheter 4, and locking sleeve 26.) between a port stem (port stem 14, fig. 2c, [0042]) and a catheter (catheter 4, fig. 2c, [0042]).
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Sanders is silent to a tear line and removal of the cathlock.
Potter, in the art of catheters, teaches a cathlock (sheath hub 208, fig. 4, [0094]) providing fluid communication ([0094] a fluid-tight seal is formed between the sheath 100 and the sheath hub 208; [0063] describes fluid tight seal between the sheath hub 208 and the cannular portion 200 of the valve housing 90, see fig. 4) between a port stem (valve housing 90, fig. 4, [0063]) and a catheter (sheath 100, fig. 4, [0063]);
a tear line (grooves 230, fig. 1, [0084]) extending along a portion of the body (frustum portion 226, fig. 1, [0084]);
grasping a portion (handle members 220, fig. 1) of the cathlock ([0084] user grabs handles 220 of cathlock 208);
urging the portion of the cathlock away from the catheter system ([0084] user applies distal pressure and radial outward force on handles 220); and
separating the cathlock along the tear line ([0084] cathlock/sheath hub 208 splits along grooves 230, see fig. 8d) ([0087] sheath hub 208 splits along grooves 230).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device/method of Sanders to include the grooves 230 and frangibility with the cathlock 26 of Sanders, as taught by the sheath hub 208 of Potter, since both references deal with catheter connectors. One would have been motivated to make the modification because, as taught by Potter [0011-0012], frangible connections between ports and sheaths are suited to certain medical situations such as when undoing a different connection such as one involving a threaded connection may cause undesirable movement of medical equipment which frangible connections can avoid.
Regarding claim 12, Sanders modified by Potter discloses the method according to claim 11, as described above, including wherein the tear line (Potter: grooves 230, fig. 1, [0084]) includes one of a score line, groove (Potter: [0087] sheath hub 208 splits along grooves 230), laser cut line, perforation, or a thinned portion of a wall of the body.
Claim(s) 11 and 12 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Pickhard in view of Potter.
Alternatively, regarding claim 11, Pickhard discloses a method of removing a cathlock from a catheter system, comprising:
providing a cathlock (two-part protective cap 10, fig. 1) including a body (11 and 12, col. 2 ln. 59-63 “two-part protective cap 10 comprising a securing device 11 and a needle protection cap 12”, fig. 1) defining a substantially cylindrical shape and extending from a first end (needle protection cap 12, fig. 1) to a second end(securing device 11, fig. 1), and
a tear line (score line 14, figs. 1 and 2) extending along a portion of the body (see figs. 1 and 2), the cathlock providing fluid communication (see hollow space in fig. 1 along length of cathlock/cap 10) between a port stem (attachment member 2, fig. 1) (col. 2 ln. 69-col. 3 ln. 2, “inwardly projecting claws 13 of the securing device 11 of the protective cap 10 acting as a base element, engaging in the annular groove 3”)and a catheter (needle carrier 5 and syringe needle 4, figs. 1 and 3) (col. 2 ln. 59-63, “At its end face 9 facing towards the syringe needle 4, the annular flange 6 is joined to a two-part protective cap 10 comprising a securing device 11 and a needle protection cap 12, the joint being obtained by ultrasonic welding.”);
grasping a portion of the cathlock (col. 3 ln. 8-14, grooving 16 on the securing device 11 and needle protection cap 12 improve the handling capacity, in particular the rotatability of the two parts with respect to each other for the purpose of breaking them apart at score line 14);
urging the portion of the cathlock away from the catheter system (col. 3 ln. 15-19, “handling capacity, in particular the rotatability of the two parts with respect to each other for the purpose of breaking them apart at score line 14”); and
separating the cathlock along the tear line (col. 3 ln. 8-14, two parts of cathlock/cap 10 break apart at score line 14, see figs. 1 and 2).
Pickhard is silent to the cathlock specifically between a port stem and a catheter.
Potter, in the art of catheters, teaches a cathlock (sheath hub 208, fig. 4, [0094]) providing fluid communication ([0094] a fluid-tight seal is formed between the sheath 100 and the sheath hub 208; [0063] describes fluid tight seal between the sheath hub 208 and the cannular portion 200 of the valve housing 90, see fig. 4) between a port stem (valve housing 90, fig. 4, [0063]) and a catheter (sheath 100, fig. 4, [0063]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Pickhard to be used with a cathlock between a port stem and a catheter, as taught by Potter, since both references deal with frangible medical connections. One would have been motivated to make the modification because, as taught by Potter [0011-0012], frangible connections between ports and sheaths are suited to certain medical situations such as when undoing a different connection such as one involving a threaded connection may cause undesirable movement of medical equipment which frangible connections can avoid.
Regarding claim 12, Pickhard modified by Potter discloses the method according to claim 11, as described above. Pickhard further discloses wherein the tear line includes one of a score line (score line 14, fig. 1, col. 3 ln. 8-14, two parts of cathlock/cap 10 break apart at score line 14), groove, laser cut line, perforation, or a thinned portion of a wall of the body.
Claim(s) 3-4, 7-8, 13-14, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over either alternative rejection as applied to claim 1 or 11 above, and further in view of Schiffer (US 5195978 A; hereafter Schiffer).
Regarding claim 3, Sanders modified by Potter, or alternatively Pickhard, discloses the peelable cathlock according to claim 1, as described above.
Either alternative rejection is silent to a frangible band.
Schiffer, in the art of catheters, teaches including a frangible band (tear strip 32, fig. 2, col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”) extending along a portion of the body (fig. 2 shows that tear strip 32 extends along a portion of the body/wall of guidewire lumen 30) and defined by a first tear line and a second tear line (see 112b interpretation above) (weakened wall sections 34 and 36, fig. 2, col. 6 ln. 27-35 “tear strip 32 formed by a pair of longitudinally extending, generally parallel weakened wall sections 34 and 36 formed in the wall of guidewire lumen 30”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Sanders and Potter, or Pickhard, to include two tear lines forming a frangible band with a pull tab, as taught by Schiffer, since Schiffer also deals with a frangible medical connection. One would have been motivated to make the modification because the pull tab and frangible band taught by Schiffer allow for a user to more carefully remove the device, first only the frangible band which would likely require less force than breaking the entire device open, and would also be less likely to cause the device to buck or displace the catheter since only a portion of the cathlock is first removed instead of the entire device breaking at once. Thus, the arrangement of Schiffer with a tear strip and pull tab allows a user to more easily, and with greater control, separate the connection along the tear lines, improving the usability of the device and the ease of the method.
Regarding claim 4, Sanders as modified, or alternatively Pickhard as modified, discloses the peelable cathlock according to claim 3, further including a pull tab (Schiffer: pull tab 38, fig. 2, col. 6 ln. 25-42) coupled to one of the body or the frangible band, proximate one of the first end or the second end (Schiffer: proximal end 24, fig. 2, col. 6 ln. 27-35 “tear strip 32…provided with a proximally disposed pull tab 38 formed at proximal end 24 of tubular shaft 22”), and configured to allow a user to grasp the pull tab and urge the pull tab away from the body to separate the body along one of the first tear line or the second tear line (Schiffer: see fig. 3, col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”).
Regarding claim 7, Sanders as modified, or alternatively Pickhard as modified, discloses the peelable cathlock according to claim 3, as described above, including wherein the frangible band (Schiffer: tear strip 32, fig. 2) extends parallel to a longitudinal axis of the body between the first end and the second end (see fig. 2) (Schiffer: col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”).
Regarding claim 8, Sanders as modified, or alternatively Pickhard as modified, discloses the peelable cathlock according to claim 3, as described above, including wherein the first tear line (Schiffer: weakened wall section 34, fig. 2, col. 6 ln. 27-35 “tear strip 32 formed by a pair of longitudinally extending, generally parallel weakened wall sections 34 and 36 formed in the wall of guidewire lumen 30”) extends from the first end to the second end (Schiffer: see fig. 3 which shows that tear strip 32 extends from proximal end 24 to distal end 26, both ends noted in col. 6 ln. 47-53) and the second tear line (Schiffer: weakened wall section 36, fig. 2, col. 6 ln. 27-35) extends along a portion of the body from one of the first end or the second end (Examiner notes that since the tear strip extends from the proximal end 24 to the distal end 26, as shown in fig. 3, the second tear line 36 extends along a portion of the body from the first end/proximal end 24.).
Regarding claim 13, Sanders modified by Potter, or alternatively Pickhard modified by Potter, discloses the method according to claim 11, as described above.
Either alternative rejection is silent to a frangible band.
Schiffer, in the art of catheters, teaches including a frangible band (tear strip 32, fig. 2, col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”) extending along a portion of the body (fig. 2 shows that tear strip 32 extends along a portion of the body/wall of guidewire lumen 30) and defined by a first tear line and a second tear line (see 112b interpretation above) (weakened wall sections 34 and 36, fig. 2, col. 6 ln. 27-35 “tear strip 32 formed by a pair of longitudinally extending, generally parallel weakened wall sections 34 and 36 formed in the wall of guidewire lumen 30”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Sanders and Potter, or Pickhard and Potter, to include two tear lines forming a frangible band with a pull tab, as taught by Schiffer, since Schiffer also deals with a frangible medical connection. One would have been motivated to make the modification because, as noted by Schiffer col. 6 ln. 32-35, “it is preferred that tear strip 32 be provided with a proximally disposed pull tab 38” and later in col. 6 ln. 47-53, Schiffer describes how the pull tab allows a user to simply facilitate the breakage of the tear strip by using the pull tab. Thus, the arrangement of Schiffer with a tear strip and pull tab allows a user to more easily separate the connection along the tear lines, improving the usability of the device and the ease of the method.
Regarding claim 14, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 13, including wherein grasping a portion of the cathlock further includes grasping (Schiffer: see fig. 3, col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”) a pull tab (Schiffer: pull tab 38, fig. 2, col. 6 ln. 25-42) coupled to one of the body (Schiffer: tubular shaft 22, fig. 2) or the frangible band (Schiffer: tear strip 32), proximate one of the first end or the second end (Schiffer: proximal end 24, fig. 2, col. 6 ln. 27-35 “tear strip 32…provided with a proximally disposed pull tab 38 formed at proximal end 24 of tubular shaft 22”).
Regarding claim 17, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 13, as described above, including wherein the frangible band (Schiffer: tear strip 32, fig. 2) extends parallel to a longitudinal axis of the body between the first end and the second end (see fig. 2) (Schiffer: col. 6 ln. 47-53, “the vascular physician simply grasps pull tab 38, preferably with forceps 40 or a similar tool to prevent slippage, and pulls tear strip 32 away from tubular shaft 22 from proximal end 24 toward distal end 26 in the direction of arrow 42”).
Regarding claim 18, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 13, as described above, including wherein the first tear line (Schiffer: weakened wall section 34, fig. 2, col. 6 ln. 27-35 “tear strip 32 formed by a pair of longitudinally extending, generally parallel weakened wall sections 34 and 36 formed in the wall of guidewire lumen 30”) extends from the first end to the second end (Schiffer: see fig. 3 which shows that tear strip 32 extends from proximal end 24 to distal end 26, both ends noted in col. 6 ln. 47-53) and the second tear line (Schiffer: weakened wall section 36, fig. 2, col. 6 ln. 27-35) extends along a portion of the body from one of the first end or the second end (Examiner notes that since the tear strip extends from the proximal end 24 to the distal end 26, as shown in fig. 3, the second tear line 36 extends along a portion of the body from the first end/proximal end 24.).
Claim(s) 5-6, 9, 15-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over either alternative art combination as applied to claim 13 above, and alternatively further in view of Su (WO 2015176222 A1; hereafter Su). Text reference is made to the Espacenet English translation of Su included with the Office Action.
Regarding claim 5, Sanders as modified, or alternatively Pickhard as modified discloses the peelable cathlock according to claim 3, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein the frangible band extends in a helical shape about a longitudinal axis of the body. This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band to have a helical shape about a longitudinal axis of the body, instead of parallel to the body. One would have been motivated to make the modification because a helical frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, Sanders as modified, or alternatively Pickhard as modified, is silent to wherein the frangible band extends in a helical shape about a longitudinal axis of the body.
Su, in the art of frangible fluid-conveying tubes, teaches wherein the frangible band (straw potion between tear marks 17, fig. 7, [0039]) extends in a helical shape about a longitudinal axis of the body (hollow tube body 12, fig. 7, [0039] tear marks 17 are a spiral dotted line along the hollow tube body 12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of either art combination to have the frangible band arranged in a helical shape about the longitudinal axis of the body, as taught by Su, since Su also deals with a frangible tube. One would have been motivated to make the modification because a helical frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem.
Regarding claim 6, Sanders as modified, or alternatively Pickhard as modified discloses the peelable cathlock according to claim 5, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body. This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band so that successive portions of the frangible band are adjacent and form the body. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, Sanders as modified, or alternatively Pickhard as modified, is silent to wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body.
A second embodiment of Su, shown in fig. 3, teaches wherein a first portion of the helical frangible band (see first portion noted in annotated Su fig. 3 below) is disposed adjacent a second portion of the helical frangible band (see second portion noted in annotated Su fig. 3 below) to form a portion of the body (hollow tube body 12, fig. 3, [0037]).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device in view of Su fig. 3 to have the helical sections of frangible band adjacent so as to form the body, since Su also deals with a frangible tube for fluid transport. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock.
Regarding claim 9, Sanders as modified, or alternatively Pickhard as modified, discloses the peelable cathlock according to claim 3, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein the frangible band extends along a portion of the body at an angle relative to longitudinal axis (see 112b interpretation above). This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band to slant relative to a longitudinal axis of the body, instead of being entirely parallel to the body. One would have been motivated to make the modification because a slanted/angled frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, either alternative art combination is silent to wherein the frangible band extends along a portion of the body at an angle relative to longitudinal axis.
Su, in the art of frangible fluid-conveying tubes, teaches wherein the frangible band (straw potion between tear marks 17, fig. 7, [0039]) extends along a portion of the body at an angle relative to longitudinal axis (hollow tube body 12, fig. 7, [0039] tear marks 17 are a spiral dotted line along the hollow tube body 12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Sanders as modified, or alternatively Pickhard as modified, to have the frangible band arranged angled relative to the longitudinal axis of the body, as taught by Su, since Su also deals with a frangible tube. One would have been motivated to make the modification because a slanted/angled frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem.
Regarding claim 15, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 13, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein the frangible band extends in a helical shape about a longitudinal axis of the body. This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band to have a helical shape about a longitudinal axis of the body, instead of parallel to the body. One would have been motivated to make the modification because a helical frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, Sanders as modified, or alternatively Pickhard as modified, is silent to wherein the frangible band extends in a helical shape about a longitudinal axis of the body.
Su, in the art of frangible fluid-conveying tubes, teaches wherein the frangible band (straw potion between tear marks 17, fig. 7, [0039]) extends in a helical shape about a longitudinal axis of the body (hollow tube body 12, fig. 7, [0039] tear marks 17 are a spiral dotted line along the hollow tube body 12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of either art combination to have the frangible band arranged in a helical shape about the longitudinal axis of the body, as taught by Su, since Su also deals with a frangible tube. One would have been motivated to make the modification because a helical frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem.
Regarding claim 16, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 15, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body. This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band so that successive portions of the frangible band are adjacent and form the body. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, Sanders as modified, or alternatively Pickhard as modified, is silent to wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body.
A second embodiment of Su, shown in fig. 3, teaches wherein a first portion of the helical frangible band (see first portion noted in annotated Su fig. 3 below) is disposed adjacent a second portion of the helical frangible band (see second portion noted in annotated Su fig. 3 below) to form a portion of the body (hollow tube body 12, fig. 3, [0037]).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device in view of Su fig. 3 to have the helical sections of frangible band adjacent so as to form the body, since Su also deals with a frangible tube for fluid transport. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock.
Regarding claim 19, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 13, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein the frangible band extends along a portion of the body at an angle relative to longitudinal axis (see 112b interpretation above). This limitation represents only a change in shape (MPEP 2144.04(IV)(B)). It would have been obvious to one of ordinary skill in the art to alter the frangible band to slant relative to a longitudinal axis of the body, instead of being entirely parallel to the body. One would have been motivated to make the modification because a slanted/angled frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Alternatively, either alternative art combination is silent to wherein the frangible band extends along a portion of the body at an angle relative to longitudinal axis.
Su, in the art of frangible fluid-conveying tubes, teaches wherein the frangible band (straw potion between tear marks 17, fig. 7, [0039]) extends along a portion of the body at an angle relative to longitudinal axis (hollow tube body 12, fig. 7, [0039] tear marks 17 are a spiral dotted line along the hollow tube body 12).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Sanders as modified, or alternatively Pickhard as modified, to have the frangible band arranged angled relative to the longitudinal axis of the body, as taught by Su, since Su also deals with a frangible tube. One would have been motivated to make the modification because a slanted/angled frangible band removes more material from the structure of the cathlock such that the remainder of the cathlock body would more easily fall away and be less likely to present further difficulty in the removal of the cathlock from the catheter system, since the form of the cathlock would be more thoroughly compromised and less likely to continue exerting sufficient linking force on the catheter and port stem.
Claim(s) 6 and 16 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over either art combination as applied to claims 5 or 15 above, and further in view of Roth (US 5405334 A; hereafter Roth).
Alternatively, regarding claim 6, Sanders as modified, or alternatively Pickhard as modified, discloses the device according to claim 5, as described above.
In a second alternative, either art combination is silent to wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body.
Roth, in the art of catheters, teaches wherein a first portion (see first portion noted in annotated Roth fig. 13a below) of the helical frangible band (single band 122, fig. 13a, col. 12 ln. 12-15) is disposed adjacent a second portion (see second portion noted in annotated Roth fig. 13a below) of the helical frangible band (col. 12 ln. 36-45, “band 122 is placed on cannula 14 in a tight helical fashion such that the leading edges 128 abut against the adjacent trailing edges 130”) to form a portion of the body (helical sheath 120, fig. 13a, col. 12 ln. 12-15, “helical sheath 120 is comprised of a single band 122”).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device in view of Roth to have the helical sections of frangible band adjacent so as to form the body, since Roth also deals with a medical tube formed in a spiral fashion. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock.
Alternatively, regarding claim 16, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 15, as described above.
In a second alternative, either art combination is silent to wherein a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body.
Roth, in the art of catheters, teaches wherein a first portion (see first portion noted in annotated Roth fig. 13a below) of the helical frangible band (single band 122, fig. 13a, col. 12 ln. 12-15) is disposed adjacent a second portion (see second portion noted in annotated Roth fig. 13a below) of the helical frangible band (col. 12 ln. 36-45, “band 122 is placed on cannula 14 in a tight helical fashion such that the leading edges 128 abut against the adjacent trailing edges 130”) to form a portion of the body (helical sheath 120, fig. 13a, col. 12 ln. 12-15, “helical sheath 120 is comprised of a single band 122”).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device in view of Roth to have the helical sections of frangible band adjacent so as to form the body, since Roth also deals with a medical tube formed in a spiral fashion. One would have been motivated to make the modification because having the cathlock formed from adjacent sections of the frangible band would better ensure that removal of the frangible band results in decoupling of the catheter and port stem, since removing the frangible band completely removes the coupling structure/cathlock.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders as modified, or alternatively Pickhard as modified, as applied to claims 1 or 11 above, and alternatively further in view of Sanders.
Regarding claim 10, Sanders as modified, or alternatively Pickhard, discloses the peelable cathlock according to claim 1, as described above.
Sanders as modified, or alternatively Pickhard, discloses the invention except for wherein the cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to choose one of a plastic, polymer, elastomer, PTFE, metal, or alloy material for the construction of the cathlock, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. (See MPEP 2144.07).
Alternatively, either alternative rejection is silent to wherein the cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material.
Sanders, in the art of cathlocks, teaches the use of a plastic ([0039] access port comprises a housing 6 constructed of a plastic material), polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material ([0040] The housing 6 may be comprised of various materials such as polymeric material, a combination of polymeric materials, metal or metal alloyed.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use one of the materials taught by Sanders regarding the housing of the access port for the cathlock as well, since Sanders teaches a medical system with an access port, catheter, and a cathlock. Materials must be selected for all three elements which are biocompatible and fluid tight. One would have been motivated to make the modification because, since the access port transports medical fluid, the noted materials associated with the access port would also be able to transport medical fluid when used in the cathlock.
Regarding claim 20, Sanders as modified, or alternatively Pickhard as modified, discloses the method according to claim 11, as described above.
Sanders as modified, or alternatively Pickhard as modified, discloses the invention except for wherein the cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to choose one of a plastic, polymer, elastomer, PTFE, metal, or alloy material for the construction of the cathlock, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. (See MPEP 2144.07).
Alternatively, either alternative rejection is silent to wherein the cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material.
Sanders, in the art of cathlocks, teaches the use of a plastic ([0039] access port comprises a housing 6 constructed of a plastic material), polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material ([0040] The housing 6 may be comprised of various materials such as polymeric material, a combination of polymeric materials, metal or metal alloyed.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use one of the materials taught by Sanders regarding the housing of the access port for the cathlock as well, since Sanders teaches a medical system with an access port, catheter, and a cathlock. Materials must be selected for all three elements which are biocompatible and fluid tight. One would have been motivated to make the modification because, since the access port transports medical fluid, the noted materials associated with the access port would also be able to transport medical fluid when used in the cathlock.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ladina et al (US 5915585 A) - see fig. 8 for example, show multiple arrangements of a frangible band in various images, including angled portion
Lee (US 6283318 B1) - see fig. 17, frangible band formed between tear lines 133
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/24/2026