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 .
Election/Restrictions
Applicant’s election without traverse of Group III, claims 23-27 and Species GGGG (Figs 93a-93c) in the reply filed on 12/8/2025 is acknowledged.
Claim Objections
Claim 23 is objected to because of the following informalities:
Claim 23 line 3, “an aspiration catheter in a blood vessel” should read “an aspiration catheter in [a] the blood vessel”
Claim 23 line 7, “the aspiration lumen to draw clot” should read “the aspiration lumen to draw the clot”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 23 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panian (US 20170333060).
Regarding Claim 23, Panian teaches (Figs 6A-6B) A method for extracting clot (610) from a blood vessel (611), said method comprising:
positioning a distal portion (606, 608) of an aspiration catheter (600, 605; see [0101 teaching how there is aspiration at proximal end of 605) in a blood vessel (611) proximal to the clot (610; see Fig 6B);
said distal portion (606, 608) of the aspiration catheter (600, 605) comprise a central clot-receiving passage (lumen of 605) through the distal portion and is contiguous with an aspiration lumen (proximal lumen of 605; see [0101] teaching aspiration at proximal end of 605) in the aspiration catheter (See Fig 6B, aspiration arrows 612 are contiguous through the device); and
applying a first level of vacuum to a proximal portion of the aspiration lumen to draw clot from the blood vessel into the distal portion of the aspiration catheter (See [0101] teaching suction starts inside aperture 609);
increasing the vacuum level after the clot has been drawn into the distal portion of the aspiration catheter, wherein the increased level of vacuum causes the distal portion to partially collapse to disrupt and/or extract the clot (See [0102] teaching once suction starts an increase of vacuum pressure leads to the 606 collapsing to create a seal around 608).
Regarding Claim 17, Panian teaches all elements of claim 23 as described above. Panian further teaches the method wherein the distal portion (606, 608) is radially expandable ( see Figs 6A-6B, 608 is radially expandable) the method further comprising: radially expanding the radially expandable distal portion (608; See Fig 6B) of the aspiration catheter in the blood vessel to form an enlarged central clot-receiving passage (609; see [0103]) through the radially expandable distal portion contiguous with the aspiration lumen in the aspiration catheter prior to increasing the vacuum level (See Fig 6B, the lumen of 602 is continuous with the lumen of 605), wherein the increased level of vacuum causes the radially expandable distal portion to partially collapse to disrupt the clot (See [0101-0102] teaching how increased vacuum pressure causes 606 to collapse to form a seal).
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.
Claim(s) 23, 17, 19 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 20110213297 hereinafter “Aklog”) in view of Sos (WO 2017074530).
Regarding Claim 23, Aklog teaches (2A-3B) A method for extracting clot (24) from a blood vessel (23; see [0038] teaching for use in a blood vessel), said method comprising:
positioning a distal portion (portion seen in Figs 2A-3B) of an aspiration catheter (25) in a blood vessel proximal to the clot (See Fig 2D; distal portion 20 is positioned proximal to 24);
said distal portion (20) of the aspiration catheter (25) comprise a central clot-receiving passage (12; see Figs 2D- 2G showing clot received in the passage) through the distal portion and is contiguous with an aspiration lumen (lumen of 25) in the aspiration catheter (see [0037] teaching the aspirated fluid is also in passageway 12); and
applying a first level of vacuum to a proximal portion of the aspiration lumen to draw clot from the blood vessel into the distal portion of the aspiration catheter (see [0038] teaching "cannula 10 may be used to introduce a suction force to the site of interest for capturing the undesirable material"; also see [0040] teaching how the suction provides a vortex flow to pull the undesirable material into the suction cannula 10);
increasing the vacuum level after the clot has been drawn into the distal portion of the aspiration catheter (See [0042] teaching that after the undesirable material 24 has been captured (drawn into distal portion 20) the suction portion may be enhanced "The suction force within pathway 12, as a result, can be enhanced to better remove the undesirable material.").
Aklog does not specify that the increased level of vacuum causes the distal portion to partially collapse to disrupt/extract the clot.
However, Aklog does teach that the distal portion may be collapsed to maneuver the cannula away from the sire of interest (see [0041]).
Similarly, Sos teaches collapsing a distal portion (110, 200) after the capture of a clot (See [0144-0145]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Aklog such that the increased level of vacuum causes the distal portion to partially collapse to disrupt/extract the clot. One of ordinary skill in the art would have been motivated to do so as both Aklog and Sos teach that it is well known to collapse a distal portion after the capture of a clot (Aklog [0041] and Sos [0144-0145]).
Regarding Claim 17, the combination of Aklog and Sos teaches all elements of claim 23 as described above. Aklog further teaches the method wherein the distal portion (20) is radially expandable (See Figs 2a-2b), the method further comprising: radially expanding the radially expandable distal portion of the aspiration catheter in the blood vessel to form an enlarged central clot-receiving passage through the radially expandable distal portion contiguous with the aspiration lumen in the aspiration catheter (See Figs 2a-2d) prior to increasing the vacuum level (See [0042]), wherein the increased level of vacuum causes the radially expandable distal portion to partially collapse to disrupt the clot (See modification done above).
Regarding Claim 19, the combination of Aklog and Sos teaches all elements of claim 17 as described above. The combination does not specify the method wherein the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter. However, Aklog does teach [0040] that the ratio between the diameter of funnel 20 and pathway 12 can be varied if desired.
As seen in Aklog [0040], the dimensions and ratio between the funnel/distal portion 20 and the pathway 12 is disclosed to be a result effective variable in that changing the ratio between the two components affects the vortex effect during suctioning of the clot. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Aklog device to have the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Aklog by making the radially expandable distal portion of the aspiration catheter partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claim 25, the combination of Aklog and Sos teaches all elements of claim 23 as described above. The combination does not specify the method wherein the distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the distal portion of the aspiration catheter. However, Aklog does teach [0040] that the ratio between the diameter of funnel 20 and pathway 12 can be varied if desired.
As seen in Aklog [0040], the dimensions and ratio between the funnel/distal portion 20 and the pathway 12 is disclosed to be a result effective variable in that changing the ratio between the two components affects the vortex effect during suctioning of the clot. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Aklog device to have the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Aklog by making the radially expandable distal portion of the aspiration catheter partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 18 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panian (US 20170333060) in view of Sos (WO 2017074530).
Regarding Claim 18, Panian teaches all elements of claim 17 as described above. Panian further teaches the method wherein the radially expandable distal portion (608) of the aspiration catheter comprises a scaffold (see [0105] teaching there is a tubular braid).
Panian does not specify that the scaffold is covered with a vacuum resistant membrane.
Panian does teach in the embodiment of (Figs 5a-5b) that the braid (508) is covered with silicone (509) that guarantees that maximum vacuum pressure could be applied ([0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Panian embodiment of figures 6a-6b, such that it includes a cover with a vacuum-resistant membrane as taught by Panian embodiment of figures 5a-5b. One of ordinary skill in the art would have been motivated to do so in order to create a shield that prevents penetration and suction of blood clots through the outer surface of the expandable tip and allows for maximum vacuum pressure to be applied (Panian [0094]).
The combination does not specify wherein struts of the scaffold act to break and/or shear the clot as the radially expandable distal portion is partially collapsed by increasing the vacuum level.
Sos teaches (Figs 14a-14b and Figs 21a-21c) a radially expandable distal portion comprising a scaffold (200) that includes struts (201a-201d). Sos further teaches as the radially expandable distal portion (200) collapses it may twist to break up the clot (see [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Panian such that it includes struts taught by Sos. One of ordinary skill in the art would have been motivated to do so as this design would aid in breaking up the clot for clot capture and aspiration (Sos [0139]).
Regarding Claim 24, Panian teaches all elements of claim 23 as described above. Panian further teaches the method wherein the distal portion (608) of the aspiration catheter comprises a scaffold (see [0105] teaching there is a tubular braid).
Panian does not specify that the scaffold is covered with a vacuum resistant membrane.
Panian does teach in the embodiment of (Figs 5a-5b) that the braid (508) is covered with silicone (509) that guarantees that maximum vacuum pressure could be applied ([0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Panian embodiment of figures 6a-6b, such that it includes a cover with a vacuum-resistant membrane as taught by Panian embodiment of figures 5a-5b. One of ordinary skill in the art would have been motivated to do so in order to create a shield that prevents penetration and suction of blood clots through the outer surface of the expandable tip and allows for maximum vacuum pressure to be applied (Panian [0094]).
The combination does not specify wherein struts of the scaffold act to break and/or shear the clot as the distal portion is partially collapsed by increasing the vacuum level.
Sos teaches (Figs 14a-14b and Figs 21a-21c) a radially expandable distal portion comprising a scaffold (200) that includes struts (201a-201d). Sos further teaches as the radially expandable distal portion (200) collapses it may twist to break up the clot (see [0139]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Panian such that it includes struts taught by Sos. One of ordinary skill in the art would have been motivated to do so as this design would aid in breaking up the clot for clot capture and aspiration (Sos [0139]).
Claim(s) 19 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panian (US 20170333060).
Regarding Claim 19, Panian teaches all elements of claim 17 as described above. Panian does not specify the method wherein the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter.
It would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Panian to include the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter since applicant has not disclosed that having the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (instant dimensions of Panian compared to the claimed range of 0.25-0.75 of the initial width). Furthermore, absent a teaching as to the criticality of the radially expandable distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the radially expandable distal portion of the aspiration catheter, 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 25, Panian teaches all elements of claim 23 as described above. Panian does not specify the distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the distal portion of the aspiration catheter.
It would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Panian to include the distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the distal portion of the aspiration catheter since applicant has not disclosed that having the distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the distal portion of the aspiration catheter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (instant dimensions of Panian compared to the claimed range of 0.25-0.75 of the initial width). Furthermore, absent a teaching as to the criticality of the distal portion of the aspiration catheter is partially collapsed to an average width in a range from 0.25 to 0.75 of an initial width of the distal portion of the aspiration catheter, 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.
Claim(s) 20- 21 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panian (US 20170333060) in view of Shadduck (US 20020095147)
Regarding Claim 20, Panian teaches all elements of claim 17 as described above. Panian does not specify the method wherein the first level of vacuum is in a range from 0 to 0.5 atmospheres.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Panian such that it is in a range from 0 to 0.5 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0 to 0.5 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0 to 0.5 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0 to 0.5 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 21, Panian teaches all elements of claim 17 as described above. Panian does not specify the method wherein the increased vacuum level is in a range from 0.2 atm to 1 atm.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Panian such that it is in a range from 0.2 to 1 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0.2 to 1 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0.2 to 1 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0.2 to 1 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 26, Panian teaches all elements of claim 23 as described above. Panian does not specify the method wherein the first level of vacuum is in a range from 0 to 0.5 atmospheres.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Panian such that it is in a range from 0 to 0.5 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0 to 0.5 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0 to 0.5 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0 to 0.5 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 27, the combination of Panian and Shadduck teaches all elements of claim 26 as described above. The combination does not specify the method wherein the increased vacuum level is in a range from 0.2 atm to 1 atm.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Panian such that it is in a range from 0.2 to 1 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0.2 to 1 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0.2 to 1 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0.2 to 1 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panian and Shadduck as applied to claim 21 above, and further in view of Garrison et al. (US 20160220741 hereinafter “Garrison”).
Regarding Claim 22, the combination of Panian and Shadduck teaches all elements of claim 21 as described above. The combination does not specify the method wherein the vacuum level is cycled up and down to enhance clot disruption after the clot has been drawn into the radially expandable distal portion of the aspiration catheter.
Garrison teaches [0114] a method of aspiration that includes aspiration force cycles between high vacuum levels and low vacuum levels to increase the ability to aspirate a thrombus through the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Panian such that it includes the step of having wherein the vacuum level is cycled up and down to enhance clot disruption after the clot has been drawn into the radially expandable distal portion of the aspiration catheter as taught by Garrison. One of ordinary skill in the art would have been motivated to do so in order to increase the ability to aspirate a thrombus through the catheter (Garrison [0114]).
Claim(s) 20-21, 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog and Sos as applied to claims 17 and 23 above, and further in view of Shadduck (US 20020095147).
Regarding Claim 20, the combination of Aklog and Sos teaches all elements of claim 17 as described above. The combination does not specify the method wherein the first level of vacuum is in a range from 0 to 0.5 atmospheres.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Aklog such that it is in a range from 0 to 0.5 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0 to 0.5 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0 to 0.5 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0 to 0.5 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 21, the combination of Aklog and Sos teaches all elements of claim 17 as described above. Aklog does not specify the method wherein the increased vacuum level is in a range from 0.2 atm to 1 atm.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Aklog such that it is in a range from 0.2 to 1 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0.2 to 1 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0.2 to 1 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0.2 to 1 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 26, the combination of Aklog and Sos teaches all elements of claim 23 as described above. Aklog does not specify the method wherein the first level of vacuum is in a range from 0 to 0.5 atmospheres.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Aklog such that it is in a range from 0 to 0.5 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0 to 0.5 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0 to 0.5 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0 to 0.5 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 27, the combination of Aklog, Sos and Shadduck teaches all elements of claim 26 as described above. The combination does not specify the method wherein the increased vacuum level is in a range from 0.2 atm to 1 atm.
Shadduck teaches a known range for suction within catheters is 0.1 atmospheres to about 2.0 atmospheres.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vacuum level of Aklog such that it is in a range from 0.2 to 1 atmospheres as taught by Shadduck. One of ordinary skill in the art would have been motivated to do so as this is a known vacuum level range used for suction within the art.
Furthermore, the instant disclosure describes the parameter of the first level of vacuum is in a range from 0.2 to 1 atmospheres as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the first level of vacuum is in a range from 0.2 to 1 atmospheres are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the first level of vacuum is in a range from 0.2 to 1 atmospheres would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aklog, Sos and Shadduck as applied to claim 21 above, and further in view of Garrison (US 20160220741).
Regarding Claim 22, the combination of Aklog, Sos and Shadduck teaches all elements of claim 21 as described above. The combination does not specify the method wherein the vacuum level is cycled up and down to enhance clot disruption after the clot has been drawn into the radially expandable distal portion of the aspiration catheter.
Garrison teaches [0114] a method of aspiration that includes aspiration force cycles between high vacuum levels and low vacuum levels to increase the ability to aspirate a thrombus through the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Aklog such that it includes the step of having wherein the vacuum level is cycled up and down to enhance clot disruption after the clot has been drawn into the radially expandable distal portion of the aspiration catheter as taught by Garrison. One of ordinary skill in the art would have been motivated to do so in order to increase the ability to aspirate a thrombus through the catheter (Garrison [0114]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783