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 (IDS) submitted on 02/20/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 02/20/26 has been entered. Claims 1, 9, 12, and 14 have been amended. Claims 2-4, 7-8, 10-11, 13, and 15-22 are in the original/ previously presented form. Claims 5-6 are cancelled. Claim 23 is newly presented. Thus, claims 1-4 and 7-22 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 08/21/25.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “one or more release valves” such as in at least claim 14 and 23 must be shown or the feature(s) canceled from the claim(s) (see 112a rejections below). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 14, line 11 recites “one or more air release valves slidingly disposed along the catheter”. On page 7 of Applicant remarks filed 02/20/26, Applicant points to [0066-0067] for support for this amendment. However, [0066] of Applicant disclosure describes:
“In some variations, at least a portion of the catheter 410 may be configured to be arranged within an introducer assembly 402, which may comprise one or more valves which may selectively permit trapped air to bleed out of the introducer assembly 402, such as through a prep tube 406. A proximal portion of the prep tube 406 may be positioned outside of the patient when the guidewire device 400 is in use, in order to allow air from inside the introducer assembly 402 to escape and help maintain hemostasis, for example.”
Thus, it seems that the air release valve is provided on the introducer assembly, not the catheter 410. Because the valve is not shown on the drawings (see drawing objection above), there is also no support from the figures for the valve disposed along the catheter. Further, the examiner consulted the current Application’s specification and figures in full and did not find any other description or figure showing a valve “slidingly” disposed on any of the structures, including the catheter. Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support the amended claim limitation, new matter has been introduced that affects the scope of the claims and is therefore rejected under 112a (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment).
Due to claim dependency, claims 15-22 are subsequently rejected under 112a.
Regarding claim 23, lines 1-2 recite “further comprising sliding one or more air release valves over the catheter”. Similar to claim 14 above, there does not appear to be any support from the specification and/or figures of the current application for the amended limitation of “further comprising sliding one or more air release valves over the catheter” as recited in claim 23. Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support the amended claim limitation, new matter has been introduced that affects the scope of the claims and is therefore rejected under 112a (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment).
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.
Claims 1-2, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King, III et al. (U.S. Patent No. 8,109,953), hereinafter King.
Regarding claim 1, King discloses a method (see col. 6 lines 31-51 describing method of disclosed device) for positioning a guidewire (15, see Fig. 5), the method comprising:
arranging (see col 6 lines 34-36: inner shaft 14 inserted into catheter 13) an inner shaft (14) at least partially within a catheter lumen (see inner shaft 14 extending through lumen of catheter 13 in Fig. 5) of a catheter (13) such that the inner shaft (14)
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is positioned at a proximal limit of longitudinal movement (see ‘Modified Fig. 5 above’, col 6 lines 31-51: inner shaft 14 inserted into catheter 13 to a proximal limit and see col. 7 lines 4-13: at hub portion of device, threaded interaction of 42/44 limit longitudinal motion of inner shaft relative to catheter) of the inner shaft (14) within the catheter lumen (see inner shaft 14 extending through lumen of catheter 13), wherein the inner shaft (14) and the catheter (13) are engageable so as to limit proximal longitudinal movement of the inner shaft (14) within the catheter lumen (13, see col. 6 lines 52-59: hub assemblies such as shown in FIG.10 allow catheter and inner shaft to be locked together==engageable to limit the relative position==limit proximal longitudinal movement);
advancing (see col 6 lines 41-43: guidewire 15 inserted into shaft until it reaches distal tip as shown in ‘Modified Fig. 5’ above) a guidewire (15) into a shaft lumen (see guidewire 15 extending through shaft lumen of inner shaft in fig. 5) of the inner shaft (14) until a distal end (rightward end of guidewire in FIG. 5) of the guidewire (15) extends distally (rightward) beyond a distal end (rightward end of catheter 13 form which the offset distance is measured) of the catheter (13) by a predetermined longitudinal offset distance (see ‘Modified FIG. 5’ above);
after advancing the guidewire (see col 6 lines 52-59: user controllably locks the device and thus can choose to lock the guidewire “after” advancing the guidewire, such as after balloon is deployed as described in col 5 lines 50-55. See also col. 7 lines 65-67: lock 49 is locked to allow inner shaft and guidewire to move together), locking the guidewire to the inner shaft (14, see col. 7 lines 32-40: inner sleeve 38== proximal end of inner shaft 14 is LOCKED TOGETHER with the guidewire. See col. 6 line 52- col. 7 line 3: describing 38 as steering sleeve==inner shaft 14. In the embodiment of Fig. 10, the structure is labeled numeral 38 at the hub region/ proximal end. Lastly, col. 7 lines 32-40 describes the locking mechanism as a conventional compression lock, aligning with Applicant disclosure in [0045]) with the distal end of the guidewire at the predetermined longitudinal offset distance (as shown in ‘Modified FIG.5’); and
after locking the guidewire (see col 5 lines 50-63: balloon holds the device in place and the “steering sleeve itself can be used to penetrate” the cap and see col 6 lines 52-59: user locks structures together and thus could lock sleeve to guidewire and advance both structures “after locking the guidewire”), advancing the guidewire (15) at least in part by advancing the inner shaft (14, 14 and 15 advanced to perforate CTO as shown in Fig. 7 and described in col. 5 lines 50-63 and col 6 lines 52-59).
Regarding claim 2, King discloses the method of claim 1, wherein arranging the inner shaft (14, see Fig. 10) comprises engaging (see col. 7 lines 4-13: 42 and 44 threaded together to limit longitudinal movement between inner shaft and catheter) a first feature (42) of the inner shaft (14, shown as 38 in Fig. 10) with a second feature (44) of the catheter (13, shown as 36 in Fig. 10).
Regarding claim 7, King discloses the method of claim 1, wherein the inner shaft (14, shown as 38 in Fig. 10) is coupled to a shaft housing (37), and locking the guidewire (15) relative to the inner shaft (38) comprises compressing (see col. 7 lines 32-40: lock 49 can be a conventional compression lock. Therefore, the lock would apply compression) the shaft housing (49 is an integral component of housing 37) around the inner shaft (38) and the guidewire (15).
Regarding claim 9, King discloses the method of claim 1, and King discloses further comprising positioning (see col. 6 lines 31-51) the guidewire (15, see FIG. 5-7) by alternately advancing (see col. 6 lines 31-51: catheter is advanced and then the inner shaft is advanced==alternately advancing to ultimately position the guidewire. See also col. 5 lines 23-32: inner shaft 14 and catheter 13 movable relative/alternately of one another to facilitate steering of the device and col 6 lines 63- col. 7 line 3 and col 7 lines 32-40: relative movement between catheter, inner shaft, and guidewire are user-controlled via locking mechanisms and thus can be alternately advanced as desired to traverse the vasculature) the inner shaft (14) and the catheter (13).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-4, 10-11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over King (U.S. Patent No. 8,109,953).
Regarding claim 3, King discloses the method of claim 2, wherein the first feature (42, see Fig. 10) is arranged on a portion of the inner shaft (38), and wherein the second feature (44) is arranged on a proximal portion (hub 35 is proximal portion) of the catheter (38), and the first feature (42) and the second feature (44) are engaged (via a threaded connection, see col. 7 lines 4-13) to define the proximal limit of longitudinal movement (see ‘Modified FIG. 5’ above and see col. 7 lines 4-13: at hub portion of device, threaded interaction of 42/44 limit longitudinal motion of inner shaft relative to catheter) of the inner shaft (38).
King in the first embodiment is silent to the first feature being arranged on a “distal” portion of the inner shaft.
However, King teaches that the hub configurations (see Fig. 10 and col. 8 lines 26-29) can include an assembly of guide tubes (see Fig. 15) snapped onto the sleeves (i.e.: inner shaft 38 and catheter 36 in Fig. 10). King further teaches the inner shaft guide tube (81) includes a first feature (see ‘Modified Fig. 15’ and ‘Modified Fig. 16’ below)
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arranged on a distal portion of the inner shaft and engages a proximal second feature (see ‘Modified FIG. 15’ and ‘Modified Fig. 16’ above) of the catheter guide tube (80).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter and inner shaft hubs disclosed in King (embodiment of FIG. 10) to include the guide tubes at the proximal and distal portions, respectively, as taught in King (embodiment of FIG. 15/16) for the purpose of aiding in the slidably positioning of the tubular elements (see col. 8 lines 30-43), thus achieving the first feature being arranged on a “distal” portion of the inner shaft.
Regarding claim 4, the modified system of King teaches the method of claim 3, and the modified system further teaches wherein at least one of the first feature and the second feature comprises a stop (see ‘Modified FIG. 16’ above).
Again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter and inner shaft hubs disclosed in King to include the guide tubes at the proximal and distal portions, respectively, as taught in King for the purpose of aiding in the slidably positioning of the tubular elements (see col. 8 lines 30-43), ensuring that “wherein at least one of the first feature and the second feature comprises a stop.”
Regarding claim 10, King discloses the method of claim 9, and King further discloses wherein at least the predetermined longitudinal offset distance (see ‘Modified FIG. 5’ above) between the guidewire (15) and the catheter (13) is maintained (see predetermined offset distance as shown in ‘Modified Fig. 5’ above. “at least” this distance is maintained in the advancement from Figure 5 to figure 6) while alternately advancing (see col. 6 lines 31-51: catheter is advanced and then the inner shaft is advanced==alternately advancing to position the guidewire.) the inner shaft (14) and the catheter (13).
Further, it would have been an obvious matter of design choice to modify the method disclosed in King to include maintaining a predetermined longitudinal offset distance between the guidewire and catheter while the inner shaft and catheter are alternatively advanced since applicant has not disclosed that having this maintained distance solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (Applicant merely discloses that the predetermined distance MAY be maintained—see [0012]—and that the predetermined distance is maintained due to a locking mechanism to ensure that the guidewire does not retract proximally into the catheter—see [0010], [0033]. Thus, it seems that any device with a mechanism for locking a guidewire’s position is capable of achieving such a maintained predetermined longitudinal offset distance). Furthermore, absent a teaching as to the criticality of the maintained predetermined longitudinal offset distance, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 11, King discloses the method of claim 9, and King further discloses wherein alternately advancing (see col. 6 lines 31-51: catheter is advanced and then the inner shaft is advanced==alternately advancing to position the guidewire and see col. 5 lines 23-32: inner shaft 14 and catheter 13 movable relative/alternately of one another to facilitate steering of the device and col 6 lines 63- col. 7 line 3 and col 7 lines 32-40: relative movement between catheter, inner shaft, and guidewire are user-controlled via locking mechanisms and thus can be alternately advanced as desired to traverse the vasculature) the inner shaft (14) and the catheter (13) comprises advancing the inner shaft (14) until a distal end (16) of the guidewire (15) encounters an obstruction (see FIG. 5 and col. 5 lines 19-35 describing device’s encounter with obstruction/ CTO), advancing the catheter (see col 5 lines 50-55: catheter advanced to position near CTO body 11, then the position is held in place by balloon 24) to reduce the distance between the distal end (16) of the guidewire (15) and a distal end of the catheter (13), and further advancing (see further advancement from FIG. 5 to FIG. 6) the inner shaft (14, see col. 5 lines 56-63: inner shaft is further advanced after catheter held in place by balloon in order to advance into the CTO body).
Further, before the effective filing date of the invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to advance the catheter to reduce the distance between a distal end of the guidewire and the distal end of the catheter because Applicant has not disclosed that advancing the catheter to reduce the distance provides an advantage, is used for a particular purpose, or solves a stated problem (Applicant merely discloses in [0057] that there is a configuration where this distance is reduced). One of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the distance between a distal end of the guidewire and the distal end of the catheter being maintained because the device is still capable of reaching the desired target location to perform treatment as required.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claim 7 above, and further in view of Goldfarb et al. (U.S. PGPUB No. 2014/0301699), hereinafter Goldfarb.
Regarding claim 8, King discloses the method of claim 7, and King further discloses wherein tightening the shaft housing (37, see Fig. 10) comprises compressing a locking mechanism (49) around at least a portion of the shaft housing (see col 7 lines 37-40: locking mechanism 49 can be a conventional compression or friction lock and see col. 7 lines 1-3: construction of lock 39, which 49 is modeled after, is any mechanical lock), but is silent to compressing specifically, a “collet”.
However, Goldfarb teaches a mechanical locking mechanism (see FIG. 15) comprising a collet (24c) that is compressed in order to lock a tubular shaft (10) in place (see [0203]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compression locking mechanism as disclosed in King with the collet as taught by Goldfarb for the purpose of centering the tubular device as the collet locking mechanism is tightened (see [0203]), thus achieving compressing specifically, a “collet”.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claims 9 and 1, respectively, above, and further in view of Righini et al. (U.S. PGPUB No. 2021/0022861), hereinafter Righini.
Regarding claim 12, King discloses the method of claim 9, but is silent “further comprising advancing the catheter into a left ventricle of a heart, and positioning the guidewire comprising alternately advancing the inner shaft and the catheter around a subvalvular space of a mitral valve behind chordae tendineae of the left ventricle”.
However, Righini teaches a method for placing an implantable heart prosthesis via a guidewire introducer system (see [0011]) comprising advancing a catheter (45, see Fig. 9) into a left ventricle of a heart (see [0098]: catheter introduced into left ventricle), and positioning a guidewire (56, see FIG. 10 and [0100]: guidewire introduced into ventricle) comprising advancing an inner shaft (44) and a catheter (36, see [0088]) around a subvalvular space of a mitral valve (V, see Fig. 9 and [0097]) behind chordae tendineae (T) of the left ventricle.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of alternatively advancing the inner shaft and catheter to position the guidewire as disclosed in King to include advancing the catheter into a left ventricle of a heart, and positioning the guidewire and the catheter around a subvalvular space of a mitral valve behind chordae tendineae of the left ventricle as taught by Righini for the purpose of avoiding guidewire entanglement in the chordae tendineae when placing an implantable heart prosthesis (see [0079]), thus achieving “further comprising advancing the catheter into a left ventricle of a heart, and positioning the guidewire comprising alternately advancing the inner shaft and the catheter around a subvalvular space of a mitral valve behind chordae tendineae of the left ventricle”.
Regarding claim 13, King discloses the method of claim 1, and King discloses locking a guidewire via the locking mechanism (49, see Fig. 10) for controllably locking/ unlocking the relative movement of the guidewire (15, see col. 7 lines 32-40: locking mechanism 49 locks guidewire relative to inner shaft), but is silent to “further comprising unlocking the guidewire and withdrawing the guidewire from the inner shaft”.
However, Righini teaches a method for placing an implantable heart prosthesis via a guidewire introducer system (see [0011]) comprising withdrawing a guidewire (56, see FIG.10 and [0099-0100]: guidewire is captured and withdrawn via catheter 45) from an inner shaft (54) of a catheter (45, see Fig. 8).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controllable locking mechanism for locking a guidewire as disclosed in King to include an unlocking step for withdrawal of the guidewire through the catheter as taught by Righini for the purpose of removing the device from the patient once the procedure is completed to enhance patient safety (see [0011]), thus achieving “further comprising unlocking the guidewire and withdrawing the guidewire from the inner shaft”.
Claims 14-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over King (U.S. Patent No. 8,109,953) in view of Bonnette et al. (U.S. PGPUB No. 2004/0210194), hereinafter Bonnette.
Regarding claim 14, King discloses a device for positioning a guidewire, the device comprising:
a catheter (13, see Fig. 5) comprising a catheter lumen (see catheter lumen housing inner shaft 14);
an inner shaft (14) arranged at least partially within the catheter lumen (see inner shaft 14 extending through lumen of catheter 13) and comprising a shaft lumen (see guidewire 15 extending through shaft lumen of inner shaft) configured to receive a guidewire (15), wherein the inner shaft (14) and the catheter (13) are engageable (see Fig. 10 and col. 7 lines 4-13: 42 and 44 threaded together to limit longitudinal movement between inner shaft and catheter) so as to limit proximal longitudinal movement (see col 6 lines 31-51: inner shaft 14 inserted into catheter 13 to a proximal limit--before the inner shaft 14 exits the catheter 13 and see col. 7 lines 4-13: at hub portion of device, threaded interaction of 42/44 limit longitudinal motion of inner shaft relative to catheter) of the inner shaft (14 or 38 in Fig. 10) within the catheter (13 or 36 in Fig. 10) lumen;
a locking mechanism (49, see Fig. 10 and col. 7 lines 32-40: locking mechanism 49 locks guidewire relative to inner shaft) arranged at a proximal portion (see proximal hub as shown in Fig. 10) of the inner catheter (14, shown as 38 in Fig. 10) and configured to lock (via mechanism 49, see col. 7 lines 32-40 disclosing a conventional compression lock, aligning with Applicant disclosure in [0045]) the guidewire (15) to the inner shaft (38) at a position in which a distal end of the guidewire (15) extends distally (rightward in FIG. 5) beyond a distal end (rightward end of catheter in FIG. 5) of the catheter (13) by a predetermined longitudinal offset distance (see ‘Modified FIG. 5’ in the rejection of claim 1 above).
King is silent to “one or more air release valves slidingly disposed along the catheter”.
However, Bonnette teaches a device for positioning a guidewire (see FIG. 1), the device comprising a catheter (introducer 46) and one or more air release valves slidingly disposed along the catheter (see [0007-0008]: introducer placed over guidewire and in slidable engagement with a sealing valve that opens to bleed out air).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter disclosed in King to include one or more air release valves slidingly disposed along the catheter as taught by Bonnette for the purpose of aiding passage of the guidewire through a self-sealing valve such that the seal is selectively opened to allow air/ fluids therethrough but otherwise remain sealed (see [0007-0008]), thus achieving “one or more air release valves slidingly disposed along the catheter”.
Regarding claim 15, the modified system of King teaches the device of claim 14, and King further discloses wherein the inner shaft (38, see Fig. 10) comprises a first feature (42) and the catheter (36) comprises a second feature (44), and wherein the first feature (42) and the second feature (44) are engageable (see col. 7 lines 4-13: 42 and 44 threaded together to limit longitudinal movement between inner shaft and catheter) so as to define a proximal limit of longitudinal movement (see ‘Modified Fig. 5’ above and see col. 7 lines 4-13: at hub portion of device, threaded interaction of 42/44 limit longitudinal motion of inner shaft relative to catheter) of the inner shaft (38) within the catheter lumen (see inner shaft 38 extending through catheter lumen in Fig. 10).
Regarding claim 16, the modified device of King teaches the device of claim 15, but is silent to “wherein at least one of the first feature and the second feature comprises a stop.”
However, King teaches that the hub configurations (see Fig. 10 and col. 8 lines 26-29) can include an assembly of guide tubes (see Fig. 15) snapped onto the sleeves (i.e.: inner shaft 38 and catheter 36 in Fig. 10). King further teaches the inner shaft guide tube (81) includes a first feature (see ‘Modified Fig. 15’ and ‘Modified Fig. 16’ above) arranged on a distal portion of the inner shaft and engages a proximal second feature comprising a stop (see ‘Modified FIG. 15’ and ‘Modified Fig. 16’ above) of the catheter guide tube (80).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter and inner shaft hubs disclosed in King to include the guide tubes at the proximal and distal portions, respectively, as taught in King for the purpose of aiding in the slidably positioning of the tubular elements (see col. 8 lines 30-43), thus achieving “wherein at least one of the first feature and the second feature comprises a stop.”
Regarding claim 19, the modified system of King teaches the device of claim 15, and King further discloses wherein the catheter (36, see Fig. 10) comprises a catheter housing (35) comprising the second feature (44).
Regarding claim 20, the modified system of King teaches the device of claim 14, and King further discloses wherein the locking mechanism (49, see Fig. 10) comprises a shaft housing (37) coupled to the inner shaft (38).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Bonnette as applied to claim 15 above, and further in view of Lei et al. (U.S. PGPUB No. 2019/0365550), hereinafter Lei.
Regarding claim 17, King discloses the device of claim 15, but is silent to “wherein the first feature comprises a first projection extending radially outward and wherein the second feature comprises a second projection extending radially inward”.
However, Lei teaches a device for positioning a guidewire comprising a limit mechanism (see FIG. 8) with engageable features between an inner shaft (6) and a catheter (7). Lei further discloses the limit mechanism inner shaft (6) with a first feature (7a) comprising a first projection (a limit pin-- see [0101]) extending radially outward (see FIG. 8 where limit pin 7a extends radially outward from shaft 7) and the limit mechanism catheter (7) with a second feature (6a) comprising a second projection (see guide groove in [0101]) extending radially inward (see FIG. 8 and [0101]: 7a retained in groove 6a and 6a seen extending radially inward from shaft 7).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the threadably engageable first and second features disclosed in King to include an engageable radially extending outward first projection and radially inwardly extending second projection as taught by Lei for the purpose of limiting relative rotational movement between the inner shaft and catheter (see Lei [0101]), thus achieving “wherein the first feature comprises a first projection extending radially outward and wherein the second feature comprises a second projection extending radially inward”.
Regarding claim 18, the modified system of King teaches the device of claim 17, but King is silent to “wherein the first projection comprises a ring arranged around a portion of the inner shaft, and wherein the second projection comprises a wall configured to abut the ring”.
However, Lei teaches a device for positioning a guidewire wherein the first projection (limit pin 7a, see FIG. 8) comprises a ring (see [0105]: 7a held in radial through hole 7b or “ring”) arranged around a portion of the inner shaft (6), and wherein the second projection (guide groove 6a) comprises a wall (see inner wall of 6a where 7b/7a abuts in FIG. 8) configured to abut the ring (7b).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the threadably engageable first and second features disclosed in King to include an engageable first and second projection wherein the first projection comprises a ring arranged around a portion of the inner shaft, and wherein the second projection comprises a wall configured to abut the ring as taught by Lei for the purpose of limiting relative rotational movement between the inner shaft and catheter (see Lei [0101]), thus achieving “wherein the first projection comprises a ring arranged around a portion of the inner shaft, and wherein the second projection comprises a wall configured to abut the ring”.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over King in view of Bonnette as applied to claim 20 above, and further in view of Goldfarb (U.S. PGPUB No. 2014/0301699).
Regarding claim 21, King discloses the device of claim 20, and King further discloses the device further comprising a locking mechanism (49, see Fig. 10) configured to tighten (see col 7 lines 37-40: locking mechanism 49 can be a conventional compression or friction lock and see col. 7 lines 1-3: construction of lock 39, which 49 is modeled after, is any mechanical lock) the shaft housing (37) around the inner shaft (38) and the guidewire (15, col. 7 lines 32-40: locking mechanism 49 locks guidewire relative to inner shaft), but is silent to tightening, specifically, a “collet”.
However, Goldfarb teaches a mechanical locking mechanism (see FIG. 15) comprising a collet (24c) that is compressed in order to lock a tubular shaft (10) in place (see [0203]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compression locking mechanism as disclosed in King with the collet as taught by Goldfarb for the purpose of centering the tubular device as the collet locking mechanism is tightened (see [0203]), thus achieving tightening, specifically, a “collet”.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over King in view of Bonnette as applied to claim 14 above, and further in view of Goldfarb et al. (U.S. PGPUB No. 2012/0071856), hereinafter Goldfarb2.
Regarding claim 22, the modified system of King teaches the device of claim 14, but is silent to “wherein a distal end of the catheter is curved”.
However, Goldfarb2 teaches a catheter device (104, see FIG. 1 and [0077]: removable guide tip 116 attached to catheter 104) for placing a guidewire (106, see FIG. 3 and [0078-0079]) wherein a distal end (132, where distal tip 116 is attached) of the catheter (104) is curved (see curved tip 116 in Fig. 1).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter disclosed in King with the detachable curved distal tip as taught by Goldfarb2 for the purpose of easily traversing different anatomical areas of a patient (see [0125]), thus achieving “wherein a distal end of the catheter is curved”.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claim 1 above, and further in view of Bonnette (U.S. PGPUB No. 2004/0210194).
Regarding claim 23, King discloses the method of claim 1, but King is silent to “further comprising sliding one or more air release valves over the catheter.”
However, Bonnette teaches a method for positioning a guidewire (see FIG. 1), the method using a catheter (introducer 46) and further comprising sliding one or more air release valves over the catheter (see [0007-0008]: introducer placed over guidewire and in slidable engagement with a sealing valve that opens to bleed out air).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in King to comprise sliding one or more air release valves over the catheter as taught by Bonnette for the purpose of aiding passage of the guidewire through a self-sealing valve such that the seal is selectively opened to allow air/ fluids therethrough but otherwise remain sealed (see [0007-0008]), thus achieving “further comprising sliding one or more air release valves over the catheter.”
Response to Arguments
Applicant's arguments filed 02/20/26 have been fully considered but they are not persuasive.
On pages 7-8 of Applicant remarks, Applicant argues that King discloses locking the guidewire and inner shaft BEFORE the guidewire is advanced and therefore the 35 U.S.C. § 102 claim rejection of at least claim 1 should be withdrawn. However, the examiner disagrees. In view of the amended limitation, the examiner has cited FIG. 7 instead of FIG. 6 as reference to the “advancing” the guidewire that occurs “after” locking the guidewire and inner shaft together. Because the device of FIG. 7 is held in place by the balloon (see col 5 lines 50-63), the inner shaft and guidewire can together be locked first (see col. 6 lines 52-59) and then advanced (both the guidewire, see col 5 line 35-38, and the inner shaft, see col 5 line 60-63, are individually capable of being advanced into the CTO. Therefore, the user can lock the guidewire and inner shaft together before advancing the guidewire without impeding the device functioning). Therefore, the examiner has maintained the 35 U.S.C. § 102 claim rejection of claim 1 under King.
At the bottom of page 8, Applicant submits that King fails to disclose the air release valves. However, a new rejection has been made under 35 U.S.C. § 103 King in view of Bonnette to address this newly amended limitation, rendering this argument moot.
No further arguments were presented. Therefore, the depending claim rejections were subsequently maintained by the examiner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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