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 07/08/2026 has/have been considered by the Examiner. Examiner thanks the Applicant for the inclusion of the explanation of relevance for CN-111765309-A, and the information disclosure statement filed 08/30/2024 has also been considered in full.
Status of the Claims
Claims 1-20 are currently pending. Claims 1-3, 9-14, and 19 are currently amended. Claims 1-20 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/26/2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Potter et al (US 20050010238 A1).
The amendments to the claims overcome the previous objections and 112(b) rejections.
Applicant argues that the Examiner’s interpretation of Pickhard’s protective needle cap 10 as a cathlock is improper. However, as previously described, the protective needle cap 10 connects two pieces of medical equipment with lumens and meets the limitations of claim 1, as previously noted in the 102 rejection of claim 1.
Applicant argues that the “Examiner’s claim construction is inconsistent with the specification’s use of the terms ‘peelable cathlock,’ ‘port stem,’ and ‘catheter.’” Examiner reiterates that the catheter and port stem are only functionally recited in claim 1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the cathlock being subcutaneous, the port stem being for a subcutaneous vascular access device, the cathlock mitigating disengagement, the fluid which is communicated being only a liquid and not a gas) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the “The Examiner’s mapping of Pickard to the claims is also inconsistent” (see Remarks pg. 8 last paragraph), and in particular argues that the mapping of a first end (needle protection cap 12, fig. 1) and a second end (securing device 11, fig. 1) of Pickhard is inconsistent with the first end attaching to a proximal end of a catheter and the second end configured to attach to a port stem. Examiner disagrees, and notes that the cited section of Pickhard col. 2 ln. 59-63 applied in the rejection of claim 1 describes the attachment of the proximal end of the catheter (needle carrier 5 and syringe needle 4, figs. 1 and 3) to both the first end (12) and second end (11). Although the first end (12) may not be in direct contact with the proximal end of the catheter, as described by Pickhard the first end (12) still meets the limitation as claimed, since the first end is attached, whether directly or indirectly, to the proximal end of the catheter.
Applicant argues that the cap of Pickhard is incapable of attaching a catheter to a port stem because the portion 12 of Pickard has a closed protective cover. There is no claim limitation at present in claim 1 that requires either the catheter or the port stem to extend outside of the peelable cathlock, nor that requires that the peelable cathlock not have a closed end.
Applicant further argues (see Remarks pg. 15 para. 2) that the characterization of the valve housing 90 of Potter as the claimed port stem and the sheath 100 of Potter as the claimed catheter is improper, since “A person of ordinary skill in the art would not consider Potter’s external hemostasis components as teaching a cathlock for subcutaneously implanted vascular access ports in a manner that is consistent with the use of the terms in the Instant Application.”. However, as previously noted, the claims do not define the catheter and/or port being subcutaneous or the catheter being used for a vascular access port. Examiner reiterates that, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Potter et al (US 20050010238 A1; hereafter Potter).
Regarding claim 1, Potter, in the art of catheters, discloses a peelable cathlock (sheath hub 208, fig. 4 and fig. 11a, [0094]), comprising:
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a body defining a cylindrical shape ([0081] sheath hub 208 defines an annular wall with an inner surface 210, as shown to good advantage in FIGS. 11A and 11B) and extending from a first end (see modified fig. 4 above, [0081]) to a second end (see modified fig. 4 above, also [0063] and [0086]), the body defining a lumen providing fluid communication between the first end and the second end (see lumen formed within cathlock 208 in fig. 4; [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), the first end ([0081] “The distal portion of the sheath hub 208 tapers as a frustum 226 to a circumference at which it interfaces with the proximal end of the splittable sheath 100”) 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 (sheath 100, fig. 4, [0063] “sheath hub 208 connected with the proximal end of a splittable sheath 100”), 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 (valve housing 90, fig. 4, [0063] valve housing 90 includes cannula portion 200 as shown in fig. 4 and “The cannula portion 200 is designed to engage with a sheath hub 208”; [0086] “The inner diameter of the sheath hub 208 defined by the inner surface 210 is the same as the outer diameter of the snap ring 202 on the cannula portion 200 of the hemostasis device 70”); and
a first tear line (one of the two grooves 230, fig. 1, [0084]) 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 ([0087] sheath hub 208 splits along grooves 230) when a force is applied ([0084] cathlock/sheath hub 208 splits along grooves 230 when user applies distal pressure and radial outward force on handles 220, see fig. 8d).
Regarding claim 2, Potter discloses the peelable cathlock according to claim 1, as described above, including wherein the first tear line (Potter: one of the 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.
Regarding claim 11, Potter, in the art of catheters, discloses a method of removing a cathlock (sheath hub 208, fig. 4 and fig. 11a, [0094]) from a catheter system, comprising:
providing the cathlock (sheath hub 208) including a body defining a substantially cylindrical shape ([0081] sheath hub 208 defines an annular wall with an inner surface 210, as shown to good advantage in FIGS. 11A and 11B) and extending from a first end (see annotated fig. 4 of Potter above, [0081] The distal portion of the sheath hub 208 tapers as a frustum 226 to a circumference at which it interfaces with the proximal end of the splittable sheath 100) to a second end (see annotated fig. 4 of Potter above, [0063] “The cannula portion 200 is designed to engage with a sheath hub 208 connected with the proximal end of a splittable sheath 100.”; [0086] “The inner diameter of the sheath hub 208 defined by the inner surface 210 is the same as the outer diameter of the snap ring 202 on the cannula portion 200 of the hemostasis device 70”), and a first tear line (one of the two grooves 230, fig. 1, [0084]) extending along a portion of the body (frustum portion 226, fig. 1, [0084]), the cathlock (208) 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 (valve housing 90, fig. 4, [0063]) and a catheter (sheath 100, fig. 4, [0063]);
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 first tear line ([0084] cathlock/sheath hub 208 splits along grooves 230, see fig. 8d) ([0087] sheath hub 208 splits along grooves 230).
Regarding claim 12, Potter discloses the method according to claim 11, as described above, including wherein the first 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) 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 first 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 first 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 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) 3-4, 7-8, 13-14, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Potter as applied to claim 1 or 11 above, and further in view of Schiffer (US 5195978 A; hereafter Schiffer).
Regarding claim 3, Potter discloses the peelable cathlock according to claim 1, as described above.
Potter is silent to a frangible band.
Schiffer, in the art of catheters, teaches further including a second tear line (weakened wall section 36, fig. 2), the first tear line and the second tear line (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”) 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) to define 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”).
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 Potter to modify the tear lines and handles of Potter with the 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. Furthermore, replacing the handles of Potter with the pull tab of Schiffer improves the security of the device, as the handles provide a larger, more obvious target for tampering with by a non-professional, and Potter does not require a specialized tool, unlike Schiffer which teaches the use of a forceps 40 to best facilitate removal of the frangible band without slipping.
Regarding claim 4, Potter 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, Potter 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, Potter 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, Potter discloses the method according to claim 11, as described above.
Potter 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 the first tear line and a second tear line (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 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 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. Furthermore, replacing the handles of Potter with the pull tab of Schiffer improves the security of the device, as the handles provide a larger, more obvious target for tampering with by a non-professional, and Potter does not require a specialized tool, unlike Schiffer which teaches the use of a forceps 40 in order to best facilitate removal of the frangible band without slipping.
Regarding claim 14, Potter as modified, discloses the method according to claim 13, as described above, including wherein grasping the 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, Potter 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, Potter 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 Potter as modified and applied above to claim 3 or 13, 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 a previous Office Action.
Regarding claim 5, Potter as modified discloses the peelable cathlock according to claim 3, as described above.
Potter 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, Potter 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 Potter as modified 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, Potter as modified discloses the peelable cathlock according to claim 5, as described above.
Potter 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, Potter 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, Potter as modified discloses the peelable cathlock according to claim 3, as described above.
Potter as modified discloses the invention except for wherein the frangible band extends along a portion of the body at an angle relative to 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 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, Potter as modified is silent to wherein the frangible band extends along a portion of the body at an angle relative to 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 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 Potter 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, Potter as modified discloses the method according to claim 13, as described above.
Potter 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, Potter 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 Potter as modified 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, Potter as modified discloses the method according to claim 15, as described above.
Potter 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, Potter 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 Potter as modified 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, Potter as modified discloses the method according to claim 13, as described above.
Potter as modified discloses the invention except for wherein the frangible band extends along a portion of the body at an angle relative to 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 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, Potter as modified is silent to wherein the frangible band extends along a portion of the body at an angle relative to 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 along a portion of the body at an angle relative to 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 Potter 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 Potter as modified, and further in view of Roth (US 5405334 A; hereafter Roth).
Alternatively, regarding claim 6, Potter as modified discloses the device according to claim 5, as described above.
In a second alternative, Potter 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.
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, Potter as modified discloses the method according to claim 15, as described above.
In a second alternative, Potter 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.
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 Potter as modified 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 Potter as applied to claims 1 or 11 above, and alternatively further in view of Sanders (US 20050124980 A1; hereafter Sanders).
Regarding claim 10, Potter discloses the peelable cathlock according to claim 1, as described above.
Potter discloses the invention except for wherein the body 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, Potter is silent to wherein the body includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material. Examiner notes that [0082] of Potter discusses catheter/sheath 100 materials including polymeric materials including tetrafluoroethylene and/or polyurethane-based thermoplastic elastomer.
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 (a polymer of tetrafluoroethylene or an elastomer) as taught by Potter regarding the catheter/sheath for the cathlock/sheath hub as well, since the sheath hub must similarly be biocompatible and fluid tight to facilitate the safe transfer of medical fluid through the system. One would have been motivated to make the modification because, since the cathlock of Potter transports medical fluid as well as the catheter of Potter, so the “suitable biocompatible, thermoplastic material” list taught by Potter regarding the catheter/sheath would also be suitable for forming the cathlock/sheath hub.
Alternatively, 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 body as well, since Sanders teaches a medical system with a connector for connecting a catheter and a port. Materials must be selected for all three elements, including the body, which are biocompatible and fluid tight. One would have been motivated to make the modification because, since the cathlock of Potter port transports medical fluid, the noted materials associated with the access port of Sanders would also be able to transport medical fluid when used in the cathlock body of Potter.
Regarding claim 20, Potter discloses the method according to claim 11, as described above.
Potter 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, Potter is silent to wherein the cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material. Examiner notes that [0082] of Potter discusses catheter/sheath 100 materials including polymeric materials including tetrafluoroethylene and/or polyurethane-based thermoplastic elastomer.
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 (a polymer of tetrafluoroethylene or an elastomer) as taught by Potter regarding the catheter/sheath for the cathlock/sheath hub as well, since the sheath hub must similarly be biocompatible and fluid tight to facilitate the safe transfer of medical fluid through the system. One would have been motivated to make the modification because, since the cathlock of Potter transports medical fluid as well as the catheter of Potter, so the “suitable biocompatible, thermoplastic material” list taught by Potter regarding the catheter/sheath would also be suitable for forming the cathlock/sheath hub.
Alternatively, 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 a connector for connecting a catheter and a port. Materials must be selected for all three elements, including the cathlock/connector, which are biocompatible and fluid tight. One would have been motivated to make the modification because, since the access port of Sanders transports medical fluid, the noted materials associated with the access port of Sanders would also be able to transport medical fluid when used in the cathlock of Potter.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/03/2026
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