DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 1, 7-12, 17 is/are objected to because of the following informalities:
Claim 1, line 2, “the catheter having a proximal end”. It should be amended as “the delivery catheter having a proximal end”.
Claim 1, lines 5-6, “the lumen of the catheter and protruding beyond the distal end of the catheter”. It should be amended as “the lumen of the delivery catheter and protruding beyond the distal end of the delivery catheter”.
Claim 1, line 8, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 1, lines 8-9, “couple the sensor to the catheter”. It should be amended as “couple the sensor to the delivery catheter”.
Claim 1, line 10, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 1, line 11, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 1, line 13, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 1, line 15, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 7, line 5, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 8, line 2, “the catheter”. It should be amended as “the delivery catheter”.
Claim 9, line 1, “the sensor”. It should be amended as “the intracorporeal sensor”.
Claim 10, line 1, “the catheter”. It should be amended as “the delivery catheter”.
Claim 11, line 1, “the catheter”. It should be amended as “the delivery catheter”.
Claim 11, line 2, “the catheter”. It should be amended as “the delivery catheter”.
Claim 11, lines 4-5, “the catheter”. It should be amended as “the delivery catheter”.
Claim 12, line 1, “the catheter”. It should be amended as “the delivery catheter”.
Claim 12, line 2, “the catheter”. It should be amended as “the delivery catheter”.
Claim 17, line 1, “wherein release mechanism”. It should be amended as “wherein the release mechanism.
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.
Claim(s) 7 is/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
Regarding claim 7, the phrase "the coupling feature" renders the claim indefinite because it is unclear whether the limitation is “the distal coupling feature” or “the proximal coupling feature” or a new coupling feature being introduced in claim 7. For the purpose of compact prosecution, “the coupling feature” in claim 7 is interpreted as “the distal coupling feature”.
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, 4, 7-9, 13-14, 16-20, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowland et al. (US 2015/0208929).
Regarding claim 1, Rowland discloses
An intracorporeal sensor delivery system (500, figs. 1-10 and pars. 0040-0052) comprising:
a delivery catheter (502, figs. 5-6 and par. 0047) comprising a lumen (lumen of 502 for 504/506/507 to be positioned within, see figs. 5-6), the catheter (502) having a proximal end (proximal end of 502. See par. 0047 disclosing 502 extending proximally to a handle assembly) and a distal end (distal end of 502, see fig. 6);
a guide wire lumen (GWL) (508, fig. 5 and par. 0048) configured to receive a guide wire (Examiner notes: the limitation “configured to receive a guide wire” is interpreted as functional limitation, and the limitation “a guide wire” is not positively recited in claim 1. See fig. 5 and par. 0048 for 508 being a guidewire lumen and allowing the insertion of a guidewire), the GWL (508) extending within the lumen of the catheter (lumen of 502 as shown in fig. 5) and protruding beyond the distal end of the catheter (distal end of 502) (Examiner notes: see fig. 5 for 508 being a lumen of 507, and see fig. 6 for 507 extending/protruding beyond the distal end of 502. Therefore, the GWL 508 protrudes beyond the distal end of 502);
an intracorporeal sensor (101 of 100, figs. 1-2 and 6. Examiner notes: see par. 0040 for 100 being a wireless pressure sensor being implanted within a blood vessel) comprising a proximal end (proximal end of 101 – that is coupled to element 102, see figs. 1-2) and a distal end (distal end of 101 – that is coupled to element 103, see figs. 1-2), wherein the proximal end of the sensor (proximal end of 101) is positioned distal to the distal end of the catheter (distal end of 502) (see figs. 6-7);
a proximal coupling feature (102, figs. 1-2, 6-8) coupled to the proximal end of the sensor (proximal end of 101), the proximal coupling feature (102) configured to removably couple the sensor (101) to the delivery catheter (502) (Examiner notes: the limitation “configured to removably couple the sensor to the delivery catheter” is interpreted as functional limitation. Rowland discloses 101 being delivered by the delivery system 500 and then implanted within a blood vessel. Therefore, 101 is configured to be removably coupled to the delivery system 500 as well as the delivery catheter 502 of the system 500); and
a distal coupling feature (103, figs. 8-9) coupled to the distal end of the sensor (distal end of 101), the distal coupling feature (103) further removably coupled to an outer surface of the GWL (outer surface of 508) at a position that is distally located with respect to the distal end of the sensor (distal end of 101, see fig. 8) (Examiner notes: see fig. 5 and par. 0048 for 507 having multiple lumens and the GWL 508 is one of the multiple lumens. See figs. 8-9 for 103 removably coupled to an outer surface of 507. Therefore, 103 is removably coupled to an outer surface of 508).
Regarding claim 2, Rowland discloses
The system of claim 1, wherein the distal coupling feature (103, figs. 8-9) comprises a loop (103, see figs. 1-2 and 8-9) that is interlaced around the outer surface of the GWL (outer surface of 508, see figs. 8-9).
Regarding claim 4, Rowland discloses
The system of claim 1, wherein the distal coupling feature (103, figs. 8-9) comprises a loop (103, see figs. 1-2 and 8-9) that is twisted or wrapped around the outer surface of the GWL (see figs. 8-9 for 103 wrapped around the outer surface of 508)
Regarding claim 7, Rowland discloses
The system of claim 1, wherein the distal coupling feature (103, figs. 8-9) comprises a loop (103, see figs. 1-2 and 8-9) that is wrapped around the outer surface of the GWL (see figs. 8-9 for 103 wrapped around the outer surface of 508) to allow, in response to the GWL being decoupled from the coupling feature, the loop to open laterally with no axial twisting (see figs. 3-4 and 21-23 for the sensor with the distal coupling feature being positioned within the blood vessel), the opened loop configured to engage walls of a vessel to provide rotational stability of the sensor (see figs. 3-4 and 21-23).
Regarding claim 8, Rowland discloses
The system of claim 1, further comprising a pressure sheath (501, fig. 5) configured to removably cover a portion of the catheter and a portion of the proximal coupling feature (Examiner notes: the limitation “configured to removably cover a portion of the catheter and a portion of the proximal coupling feature” is interpreted as functional limitation. See fig. 5 and par. 0047 for 101 being delivered through 501, 501 is capable of removably cover a portion of 502 and 102).
Regarding claim 9, Rowland discloses
The system of claim 1, wherein the sensor (101) is a pressure sensor (see par. 0040).
Regarding claim 13, Rowland discloses
An intracorporeal sensor delivery system (500, figs. 1-10 and pars. 0040-0052) comprising:
a first lumen (508, fig. 5) configured to receive a guide wire lumen (GWL) (Examiner notes: the limitation “configured to receive a guide wire lumen GWL” is interpreted as functional limitation, and the limitation “a guide wire lumen” is not positively recited/claimed/required in claim 13. See par. 0048 for 508 allowing an insertion of a guidewire; therefore, 508 is capable of receiving a guide wire lumen);
the GWL configured to extend beyond a distal end of the first lumen, the GWL configured to removably receive a distal coupling feature coupled to an outer surface of the GWL at a position that is distally located with respect to the distal end of the lumen, the distal coupling feature interconnected with a sensor (Examiner notes: as set forth above, the guide wire lumen GWL is not positively recited/claimed/required in claim 13. Therefore, this phrasing limitation for GWL is not positively recited/claimed/required in claim 13. See par. 0048 for 508 allowing an insertion of a guidewire; therefore, 508 is capable of receiving a guide wire lumen and allowing the guide wire lumen to extend beyond the distal end of 508. The limitations “a distal coupling feature”, “an outer surface of the GWL”, and “a sensor” are not positively recited/claimed/required in claim 13); and
a second lumen (509 or 510, fig. 5) configured to convey a release mechanism (Examiner notes: the limitation “configured to convey a release mechanism” is interpreted as a functional limitation, and the limitation “a release mechanism” is not positively recited/claimed/required in claim 13. See fig. 5 and par. 0048 for lumen 509 allowing insertion of tie 511 and lumen 510 allowing insertion of tie 512; therefore, lumens 509/510 are capable of conveying a release mechanism), the release mechanism configured to removably couple with a proximal end of the sensor (Examiner notes: as set forth above, the release mechanism is not positively recited/claimed/required in claim 13; therefore, this phrasing limitation for the release mechanism is not positively recited/claimed/required in claim 13. Also, the limitations “a proximal end of the sensor” and “the sensor” are not positively recited/claimed/required in claim 13), wherein the first (508) and second (509/510) lumens are positioned in parallel and held together (see fig. 5 and par. 0048).
Regarding claim 14, Rowland discloses
The system of claim 13, wherein the release mechanism is a floss or a threaded fastener (Examiner notes: as set forth above, the release mechanism is not positively recited/claimed/required in claim 13. Therefore, this phrasing limitation for the release mechanism in claim 14 is not positively recited/claimed/required).
Regarding claim 16, Rowland discloses
The system of claim 13, further comprising a pressure lumen positioned in parallel and held together with the first and second lumens (Examiner notes: see fig. 5 and par. 0048 for 507 having multiple lumens 508, 509, and 510. Examiner interpreted 508 as a first lumen, 509 as a second lumen, and 510 as a pressure lumen. Lumen 510 is configured to assist tie 510 to hold the pressure sensor 101 in place, therefore, 510 is read as a pressure lumen. See fig. 5 for 508, 509, and 510 being parallel and held together within 507).
Regarding claim 17, Rowland discloses
The system of claim 13, wherein release mechanism is a floss, wherein the release mechanism is configured to extend through a hole or a ring in the proximal end of the sensor (Examiner notes: as set forth above, the release mechanism is not positively recited/claimed/required in claim 13. Therefore, this phrasing limitation for the release mechanism in claim 17 is not positively recited/claimed/required).
Regarding claim 18, Rowland discloses
An intracorporeal sensor delivery system (500, figs. 1-10 and pars. 0040-0052) comprising:
a catheter (502, figs. 5-6 and par. 0047) comprising a lumen (lumen of 502 for 504/506/507 to be positioned within, see figs. 5-6), the catheter (502) having a proximal end (proximal end of 502. See par. 0047 disclosing 502 extending proximally to a handle assembly) and a distal end (distal end of 502, see fig. 6);
a guide wire lumen (GWL) (508, fig. 5 and par. 0048) configured to receive a guide wire (Examiner notes: the limitation “configured to receive a guide wire” is interpreted as functional limitation, and the limitation “a guide wire” is not positively recited in claim 1. See fig. 5 and par. 0048 for 508 being a guidewire lumen and allowing the insertion of a guidewire), the GWL (508) extending within the lumen of the catheter (lumen of 502 as shown in fig. 5) and protruding beyond the distal end of the catheter (distal end of 502) (Examiner notes: see fig. 5 for 508 being a lumen of 507, and see fig. 6 for 507 extending/protruding beyond the distal end of 502. Therefore, the GWL 508 protrudes beyond the distal end of 502); and
a distal coupling feature (103, figs. 8-9) coupled to a distal end of a sensor (distal end of 101), the distal coupling feature (103) further removably coupled to an outer surface of the GWL (outer surface of 508) at a position that is distally located with respect to the distal end of the catheter (distal end of 502, see fig. 6) (Examiner notes: see fig. 5 and par. 0048 for 507 having multiple lumens and the GWL 508 is one of the multiple lumens. See figs. 8-9 for 103 removably coupled to an outer surface of 507. Therefore, 103 is removably coupled to an outer surface of 508).
Regarding claim 19, see the rejection of claim 2 above.
Regarding claim 20, Rowland discloses
The system of claim 18, further comprising a proximal coupling feature (102, figs. 1-2 and 6-8) configured to removably couple to a proximal end of the sensor (proximal end of 101), wherein the proximal coupling feature (102) is one of a floss, a threaded fastener, a snare (figs. 1-2), paddles, or detents.
Regarding claim 22, Rowland discloses
The system of claim 18, wherein the catheter (502) comprises a pressure sheath (501) configured to measure pressure (Examiner notes: the limitation “configured to measure pressure” is interpreted as functional limitation. See par. 0047 for the pressure sensor 101 being delivered through 501 to measure the pressure within a blood vessel).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland et al. (US 2015/0208929).
Regarding claim 5, Rowland embodiment in fig. 5 discloses the system of claim 1, as set forth above, except for wherein the proximal coupling feature comprises a loop that is twisted at least once around itself.
However, Rowland teaches different embodiments of the sensor (see figs. 1-2 and pars. 0040-0042) with different configurations of the proximal and distal coupling features (see figs. 1-2) wherein the coupling feature comprises a loop that is twisted at least once around itself (see figs. 1-2).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the proximal coupling feature to have a loop, as taught by Rowland different embodiments, since Rowland teaches the coupling features can be of different sizes and shapes depending on the target location and intended function (par. 0040 of Rowland).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland et al. (US 2015/0208929) in view of Von Oepen et al. (US 2012/0259399).
Regarding claim 6, Rowland embodiment in fig. 5 discloses the system of claim 1, as set forth above, except for wherein the GWL comprises a length, wherein a first portion of the length has a first stiffness, and a second portion of the length has a second stiffness that is different from the first stiffness.
However, Von Oepen teaches a catheter (2000, figs. 22A-22B) being steered by a guidewire (par. 0102) wherein the catheter includes a distal end with at least two sections of different longitudinal stiffness (par.0102).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the distal end of Rowland GWL to have different longitudinal stiffness sections, as taught by Von Oepen, for the purpose of allowing the system to navigate through the branches geometry of the blood vessels (par. 0102 of Von Oepen).
Claim(s) 10, 21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland et al. (US 2015/0208929) in view of Curry (US 2009/0024015).
Regarding claim 10, Rowland discloses the system of claim 1, as set forth above, except for wherein the catheter further comprises a second lumen extending parallel with respect to the lumen.
However, Curry teaches a multilumen catheter (30, fig. 2) with a second lumen extending parallel with respect to the lumen (see fig. 4A for one lumen with the sensing element 10 and the other lumen extending parallel).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Rowland catheter by having another lumen extending parallel to its lumen, as taught by Curry, for the purpose of providing access for other device to be inserted into the patient (par. 0034 of Curry).
Regarding claim 21, Rowland discloses
The system of claim 18, wherein the system (500) further comprising a torque cable (506, figs. 6-7 and pars. 0048-0050), the torque cable (506) comprising a proximal coupling feature (proximal end of 506. See par. 0047 disclosing 506 extending proximally to a handle assembly) configured to removably couple to a proximal end of the sensor (proximal end of 101) (see fig. 7 and par. 0048).
Rowland is silent about the catheter comprising a second lumen, and the torque cable extending through the second lumen.
However, Curry teaches a multilumen catheter (30, fig. 2) with a second lumen (see fig. 4A for one lumen with the sensing element 10 and the other lumen extending parallel) wherein one of the lumens is used for a probe or other device (par. 0034).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Rowland catheter by having another lumen for the torque cable, as taught by Curry, for the purpose of providing a separate access for the torque cable for easy access.
Regarding claim 23, Rowland discloses
The system of claim 18, wherein a push rod (506, figs. 6-7) comprising a cutting element or torque cable (506, figs. 6-7 and pars. 0048-0050).
Rowland is silent about the catheter comprises a second lumen, and the torque cable extending through the second lumen.
However, Curry teaches a multilumen catheter (30, fig. 2) with a second lumen (see fig. 4A for one lumen with the sensing element 10 and the other lumen extending parallel) wherein one of the lumens is used for a probe or other device (par. 0034).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Rowland catheter by having another lumen for the torque cable, as taught by Curry, for the purpose of providing a separate access for the torque cable for easy access.
Regarding claim 24, Rowland discloses the system of claim 18, as set forth above, except for wherein the catheter comprises a second lumen configured to facilitate pressure readings.
Rowland only discloses the catheter (502) having the lumen configured to facilitate pressure readings (Examiner notes: the lumen of 502 is for 506 to place the pressure sensor 101 within a blood vessel; therefore lumen of 502 is configured to facilitate pressure readings from the pressure sensor 101).
However, Curry teaches a multilumen catheter (30, fig. 2) with a second lumen (see fig. 4A for one lumen with the sensing element 10 and the other lumen extending parallel) wherein one of the lumens is used for a probe or other device (par. 0034).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Rowland catheter by having another lumen for the positioning rod, as taught by Curry, for the purpose of providing a separate access for the positioning rod for easy access.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowland et al. (US 2015/0208929) in view of Wallace et al. (US 2019/0247188).
Regarding claim 15, Rowland discloses the system of claim 13, as set forth above, except for further comprising a cutter mechanism extending within the second lumen, the cutter mechanism configured to sever the release mechanism.
Examiner notes: the limitation “configured to sever the release mechanism” is interpreted as functional limitation, and as set forth above, the release mechanism is not positively recited/claimed/required in claim 13. Therefore, the phrasing limitation for the release mechanism in claim 15 is not positively recited/claimed/required.
Rowland only discloses disengaging, retracting, or breaking ties or wires to deploy the implant/sensor from the system (par. 0048). Rowland is silent how to break the ties or wires.
However, Wallace teaches a cutting mechanism (1515, figs. 15A-15D) extending within a lumen (see fig. 15C for lumen of 1515), the cutter mechanism (1515) configured to sever the release mechanism (1526).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Rowland by adding a cutting mechanism, as taught by Wallace, for the purpose of aiding in cutting/breaking Rowland ties or wires when needed.
Allowable Subject Matter
Claim(s) 3, 11-12 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783