DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Objections
Claims 25 and 26 are objected to because they recite “m/min" and does not specify "m". As best understood, the claims should say "ml/min".
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "power synchronizer" in claim 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23, 27 and any claims depending therefrom 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 23, the limitation “a power synchronizer operably coupled to the aspiration control system and configured to synchronize the delivery of power between a vacuum source and the vacuum controller” lacks antecedent basis in the claim for “the delivery of power between a vacuum pump and the vacuum controller”. Further, it is not clear what is meant by "synchronize power", i.e., whether it means synchronize a specific amount of power or synchronize any delivery of power temporally.
Regarding claim 37, the limitation "the flow sensor" lacks antecedent basis in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,931,502 (hereinafter "the '502 patent") in view of Sorensen et al (U.S. Pub. 2013/0150782 A1, hereinafter "Sorensen").
Although the claims are not identical, they are not patentably distinct because:
The vacuum line, receptacle, aspiration tubing, aspiration catheter, sensor, vacuum controller, and regulator of claim 22 correspond to the structural components utilized in performing the method of claim 1 of the '502 patent. In other words, claim 22 is an apparatus claim that comprises all the structure that is used to carry out the method claim 1 of the '502 patent, with the exception that claim 22 recites a vacuum controller that compares the flow parameter to a limit for the flow parameter—whereas claim 1 of the '502 patent recites comparing the flow parameter to a target range for the flow parameter (without specifying what, or who, performs this step).
But since a target range necessarily has a lower limit and an upper limit, a method of comparing a flow parameter to a target range necessarily requires comparing the flow parameter to a limit to determine whether the parameter is higher or lower than the limit. Therefore, this specific limitation of claim 22 is covered by the broader limitation present in claim 1 of the '502 patent.
Further, though claim 22 recites that the comparison step is configured to be carried out by a vacuum controller, this limitation is obvious over the '502 patent in view of Sorensen. Specifically, Sorensen discloses a method of controlling vacuum pressure in an aspiration line, comprising measuring a flow parameter of the aspirated fluid within aspiration tubing 52 (Fig. 3) using a sensor (such as a pressure sensor 63; see Fig. 3); receiving the flow parameter from the sensor at a vacuum controller 40 (see para [0043]); comparing the flow parameter to a target for the flow parameter (see para [0048] disclosing a controller comparing the pressure reading from the sensor 63 to set thresholds); and sending an automatic control signal to a regulator based on a comparison of the flow parameter to the target. Accordingly, a skilled artisan would have found it obvious at the time of the invention to use a vacuum controller to carry out the method step of comparing the flow parameter to a limit for the flow parameter, based on the teaching in Sorensen of using well-known electronic controllers to quickly and accurately compare the flow parameter to a target for the flow parameter in an improved manner over manual or by-hand comparison.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of the '502 patent.
Although the claims are not identical, they are not patentably distinct because:
Claim 22 is an apparatus claim that comprises all the structure of claim 15 of the '502 patent, with the exception that claim 22 recites a vacuum controller that compares the flow parameter to a limit for the flow parameter—whereas claim 15 of the '502 patent recites a vacuum controller that compares the flow parameter to a target range for the flow parameter.
But since a target range necessarily has a lower limit and an upper limit, a method of comparing a flow parameter to a target range necessarily requires comparing the flow parameter to a limit to determine whether the parameter is higher or lower than the limit. Therefore, this specific limitation of claim 22 is covered by the broader limitation present in claim 15 of the '502 patent.
Further, claim 22 recites that the automatic control signal causes the regulator to adjust the vacuum pressure within the vacuum line and within the receptacle when the aspiration control system is in the assembled configuration; this limitation is similar to claim 1 of the '205 patent, which recites that the automatic control signal causes the regulator to adjust the vacuum pressure within the vacuum line and within the receptacle by manipulating the valve that opens the vacuum line to the atmosphere. In the '205 patent, it is necessary for the aspiration control system to be assembled in order to manipulate the valve that opens the vacuum line to the atmosphere.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,717,603 (hereinafter "the 603 patent") in view of Sorensen et al (U.S. Pub. 2013/0150782 A1, hereinafter "Sorensen").
Although the claims are not identical, they are not patentably distinct because:
Claim 22 is an apparatus claim that comprises all the structure of claim 1 of the '603 patent, with the exception that claim 22 recites a vacuum controller that compares the flow parameter to a limit for the flow parameter—whereas claim 1 of the 603 patent recites a vacuum controller that compares the flow parameter to a target range for the flow parameter.
But since a target range necessarily has a lower limit and an upper limit, a method of comparing a flow parameter to a target range necessarily encompasses comparing the flow parameter to a limit to determine whether the parameter is higher or lower than the limit. Therefore, this specific limitation of claim 22 is covered by the broader limitation present in claim 1 of the '603 patent.
Further, claim 22 recites that the automatic control signal causes the regulator to adjust the vacuum pressure within the vacuum line and within the receptacle when the aspiration control system is in the assembled configuration; this limitation is similar to claim 1 of the 603 patent, which recites that the automatic control signal causes the regulator to adjust the vacuum pressure within the vacuum line and within the receptacle. In the ‘603 patent, it is necessary for the aspiration control system to be assembled in order to manipulate the valve that opens the vacuum line to the atmosphere.
The following claims are also on the ground of nonstatutory double patenting as being unpatentable over claims of the '502 patent:
Claim 23 is unpatentable over claim 23 of the '502 patent.
Claim 24 is unpatentable over claim 25 of the '502 patent.
Claim 27 is unpatentable over claim 15 of the '502 patent.
Claim 28 is unpatentable over claim 15 of the '502 patent.
Claim 29 is unpatentable over claim 22 of the '502 patent.
Claim 30 is unpatentable over claim 16 of the '502 patent.
Claim 31 is unpatentable over claim 24 of the '502 patent.
Claim 33 is unpatentable over claim 26 of the '502 patent.
Claim 34 is unpatentable over claim 19 of the '502 patent.
Claim 35 is unpatentable over claim 20 of the '502 patent.
Claim 36 is unpatentable over claim 21 of the '502 patent.
Claim 37 is unpatentable over claim 25 of the '502 patent.
Claim 39 is unpatentable over claim 24 of the '502 patent.
Claim 40 is unpatentable over claim 24 of the '502 patent.
The following claims are also on the ground of nonstatutory double patenting as being unpatentable over claims of the ‘603 patent:
Claim 23 is unpatentable over claim 10 of the '603 patent.
Claim 24 is unpatentable over claim 1 of the '603 patent.
Claim 25 is unpatentable over claim 1 of the '603 patent.
Claim 31 is unpatentable over claim 19 of the '603 patent.
Claim 34 is unpatentable over claim 7 of the '603 patent.
Claim 35 is unpatentable over claim 8 of the '603 patent.
Claim 39 is unpatentable over claim 14 of the '603 patent.
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.
Claims 22 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (U.S. Pub. 2012/0059340 A1, hereinafter "Larsson") in view of Sorensen et al (U.S. Pub. 2013/0150782 A1, hereinafter "Sorensen") or Barwick, Jr. et al (U.S. Pat. 5,591,127 A, hereinafter “Barwick”).
Regarding claim 22, Larsson discloses an aspiration control system for controlling blood loss during thrombus removal (such as removal of a thrombus “C” shown in Fig. 3), the aspiration control system comprising:
a receptacle for blood collection 2 (Fig. 3);
an aspiration tubing 3 configured to fluidically couple the receptacle 2 to an aspiration catheter 4 when the aspiration control system is in an assembled configuration (Fig. 3);
a vacuum line 10 configured to fluidically couple the receptacle 2 to a vacuum source, such as vacuum pump 1, in the assembled configuration (Fig. 3; see also para. [0017] disclosing that vacuum pump 1 is connected to drainage fluid collection container 2 by tube 10);
a sensor configured to measure a flow parameter associated with a liquid in the aspiration tubing 3 (see para. [0017] disclosing that a pressure sensor 8 can be placed in aspiration tubing 3, wherein the sensor measures a pressure parameter associated with blood flowing through the aspiration tubing);
a vacuum regulator configured to be fluidically coupled to the vacuum line 10, wherein the vacuum regulator adjusts a vacuum pressure within the vacuum line and within the receptacle 2 (see para. [0024] disclosing a controller 9 that can physically control a suction pump 1; the vacuum regulator is the portion of the controller that varies the operation of the pump);
and a vacuum controller operably coupled to the sensor and the vacuum regulator and configured to communicate with the regulator (see para. [0020] disclosing that pressure sensor 8 is read by controller 9, or sends measured data to controller 9, and that controller 9 controls operation of vacuum pump 1 based on the measured data; the portion of the controller 9 that carries out these tasks constitutes the vacuum controller), the vacuum controller configured to:
receive the flow parameter from the sensor (see para. [0020] disclosing that controller 9 receives measured data from pressure sensor 8);
wherein the automatic control signal causes the regulator to adjust the vacuum pressure within the vacuum line 10 and within the receptacle 2 when the aspiration control system is in the assembled configuration (see paras. [0021]-[0022] disclosing that vacuum pump 1 adjusts the negative pressure P1 within vacuum line 10 and receptacle 2, thereby controlling aspiration through aspiration tubing 3 and aspiration catheter 4; these steps implicitly occur in an assembled configuration).
It is noted that Larsson does not appear to disclose that the vacuum controller is configured to compare the flow parameter to a limit for the flow parameter; and send an automatic control signal to the regulator based on a comparison of the flow parameter to the limit.
However, para. [0024] of Larsson discloses that the vacuum controller determines from pressure sensor 8 that the clot C has been removed and the drainage lumen is open again, thus permitting the controller to send a signal to the vacuum regulator to automatically decrease the suction power in the vacuum pump 1.
Further, Sorensen discloses a method of controlling vacuum pressure in an aspiration line, comprising measuring a flow parameter of the aspirated fluid within aspiration tubing 52 (Fig. 3) using a sensor (such as a pressure sensor 63; see Fig. 3); receiving the flow parameter from the sensor at a vacuum controller 40 (see para. [0043]);
comparing the parameter to a limit for the parameter (see para. [0048] disclosing a controller comparing the pressure reading from the sensor 63 to set thresholds); and sending an automatic control signal to a regulator based on a comparison of the flow parameter to the limit (see para. [0048] disclosing that when the pressure sensor 63 detects that the aspiration pressure has exceeded a predetermined threshold, the controller can "modify the aspiration pressure within aspiration line 52").
Alternatively, Barwick discloses a method of controlling vacuum pressure in an aspiration line of a surgical system in response to an occlusion condition, comprising measuring a flow parameter of the aspirated fluid within aspiration tubing using a sensor (see col.2, lines 17-22, disclosing a vacuum sensor 24, which provides input to controller 18 representing vacuum level on the output side of a pump 14);
comparing the parameter to a limit for the parameter, and sending an automatic control signal to a regulator based on a comparison of the flow parameter to the limit (see col. 2, lines 37-50, disclosing when the vacuum level sensed by the sensor 24 reaches a predetermined level, the computer instructs the pump controller 20 to change the speed of the pump, which in turn changes the aspiration rate; these steps would have been understood to implicitly require a comparison of the sensed level to the predetermined limit).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to use a vacuum controller to carry out the functionality of comparing the flow parameter to a limit for the flow parameter and sending an automatic control signal to a regulator based on a comparison of the flow parameter to the limit, based on the teaching in Sorensen or Barwick that making comparisons of sensor data to flow parameter limits was well-known at the time of the invention to modulating vacuum in an aspiration line. A skilled artisan would have had a reasonable expectation of success in using the compared information to modulate the vacuum pump in Larsson, for example, by obtaining a pressure value of 0 from a pressure sensor and then comparing that to a threshold value of 0; if the obtained pressure and threshold match, then Larsson can carry out its intended function disclosed in para. [0024], namely, indicating that the clot C has been removed and sending a signal to the vacuum regulator to automatically decrease suction power in the vacuum pump.
Regarding claim 27 and 28, Larsson, in view of Sorensen or Barwick, discloses the aspiration control system of claim 22, wherein the vacuum regulator opens the vacuum line to the atmosphere in order to adjust the vacuum pressure within the vacuum line upon receipt of the automatic control signal, wherein the regulator comprises a valve configured to open the vacuum line to the atmosphere upon receipt of the automatic control signal (Larsson discloses a valve 7 that opens the vacuum line to atmosphere via the auxiliary lumen, as illustrated in Fig. 2, in order to change the vacuum pressure within the vacuum line, upon receipt of the signal; see also para [0022]).
Regarding claim 29, Larsson, in view of Sorensen or Barwick, discloses the aspiration control system of claim 22, wherein the vacuum line comprises a disposable portion and a reusable portion, and in the assembled configuration the disposable portion extends between the receptacle and a connector and the reusable portion extends between the connector and the regulator (i.e., any part of the device can be reused and/or disposed).
Regarding claim 30, Larsson, in view of Sorensen or Barwick, discloses the aspiration control system of claim 22, wherein the receptacle comprises an intake port configured for fluidic coupling to the aspiration tubing and a vacuum port configured for fluidic coupling to the vacuum line (see Larsson at Fig. 1, showing schematically the receptacle connected to the aspiration tubing and the vacuum line; the receptacle necessarily includes an inlet opening configured to receive the aspiration tubing and a second opening configured to receive the vacuum line, which constitute the claimed intake port and vacuum port).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Larsson, in view of Sorensen or Barwick, further in view of Adie et al (WO2013064852 A1, hereinafter “Adie”).
Regarding claim 23, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising a power synchronizer operably coupled to the aspiration control system and configured to synchronize the delivery of power between a vacuum source and the vacuum controller.
Adie discloses a vacuum controller (see para [0007]) associated with a vacuum pump (see paras [0007] and [0104]) and a sensor which is able to synchronize the delivery of power of the pump and the vacuum controller. For instance, Adie discloses a sensor that can sense a controller error and shut down power to a pump, thus synchronizing the delivery of power between the pump and the controller (see para [0157]).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Larsson, in view of Sorensen or Barwick, in order to provide a power synchronizer as taught in Adie, in order to provide a known means for performing tests before using the aspiration system and to stop the pump if a controller error is sensed, thus improving the operation of the system.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson, in view of Sorensen or Barwick, further in view of Zacharias (U.S. Pub. 2010/0185150 A1, hereinafter “Zacharias”).
Regarding claim 24, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, wherein the flow parameter is a flow rate.
Zacharias discloses an aspiration system, comprising a control module that uses a feedback loop to operate a regulator until a determined level of vacuum in an aspiration path is achieved (See para [0227]). Zacharias teaches that the control module can take into account various factors such as vacuum level or aspiration flow rate (Id.).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Larsson, in view of Sorensen or Barwick, so that the flow parameter is an aspiration flow rate instead of, or in addition to, pressure, as taught in Zacharias, as aspiration flow rate was a well-known factor for use in controlling a determined level of vacuum in an aspiration path; and in doing so, a skilled artisan would have had a reasonable expectation of success in controlling the vacuum level of Larsson.
Further, regarding claims 25 and 26, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose that the limit for the flow parameter is a flow rate between about 70 m/min and about 130 m/min or about 90 m/min and about 130 m/min.
Zacharias teaches that an occlusion event can lead to spikes in the aspiration rate about 80 ml/min (see para [0012]).
Accordingly, a skilled artisan would have found it obvious to choose the limit to be 80 ml/min, which falls within the claimed ranges of both claims (i.e., 80 ml/min is “about 90 ml/min” and falls within the range of 70-130 ml/min), as Zacharias teaches that this was a well-known limit for an aspiration flow rate that indicates an occlusion, and in doing so, a skilled artisan would have had a reasonable expectation of success in comparing the flow parameter to a parameter known to indicate the occlusion.
Additionally, choosing a specific value for the limit of aspiration flow rate would have been within the level of ordinary skill in the art at the time of the invention, as a matter of routine optimization, absent the criticality of choosing a limit within the claimed ranges.
Claims 31-33 and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson, in view of Sorensen or Barwick, further in view of Teigen et al (U.S. Pub. 2020/0367917 A1, hereinafter "Teigen").
Regarding claims 31-33, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising a manual override system including a clamp in operable communication with the vacuum controller, the clamp configured to stop a flow of liquid through the aspiration tubing when the aspiration control system is in an assembled configuration;
wherein the manual override system further includes a foot pedal;
and the aspiration control system of claim 31, wherein operation of the clamp to stop a flow of liquid through the aspiration tubing is associated with a surge protection signal that causes the regulator and/or vacuum controller to reduce the vacuum pressure within the vacuum line.
Teigen discloses an aspiration system for controlling blood loss during thrombus removal (see para [0006], disclosing a method of using a pump labeled "PRIOR ART" in Fig. 1), comprising: an aspiration catheter (not shown, but disclosed in para [0006] as a "reperfusion catheter... which has been introduced to the vasculature of a patient to aspirate clot"); an aspiration tubing 22 (see Fig. 1) fluidically coupled to the aspiration catheter (see para [0006] disclosing that the aspiration tube 22 is connected to a reperfusion catheter which has been introduced to the cerebral vasculature of a patient to aspirate clot); an aspiration lumen extending through the aspiration catheter and the aspiration tubing (i.e., the aspiration lumen is the channel formed through both the aspiration catheter and aspiration tubing); a vacuum line 30 (Fig. 1) fluidically coupled to the receptacle and configured to transfer vacuum pressure from a vacuum source to the receptacle. Teigen further discloses a manual override whereby the user can manually conduct aspiration for a predetermined period of time. If the system detects unrestricted flow, then the on-off valve is turned off to stop flow. The user can manually trigger a mechanism (such as a foot pedal or manual switch) to initiate further aspiration (see para [0103]). The manual override is associated with a normal algorithm that is associated with surge protection by specifically being designed to override the algorithm (see paras. [0072] and [0103]).
Regarding claims 39-41, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising a manual input in operable communication with one or more of the vacuum controller, the regulator, and a receptacle vent, wherein the manual input is configured to accept a manual command and send a manual control signal responsive to the manual command to one or more of the vacuum controller, the regulator, and the receptacle vent;
the aspiration control system of claim 39, wherein the manual control signal overrides the automatic control signal at one or more of the vacuum controller, the regulator, and the receptacle vent; and
the aspiration control system of claim 39, wherein the manual input is a button in operable communication with the vacuum controller.
Teigen discloses the system as described above, comprising a manual control signal in the form of a manual override whereby the user can manually conduct aspiration for a predetermined period of time. The manual override is used to override the normal flow algorithm (see paras. [0072] and [0103]) and can be in the form of a button (i.e., a pedal (see para. [0103]). If the system detects unrestricted flow, then the on-off valve is turned off to stop flow.
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the aspiration system of Larsson, in view of Sorensen or Barwick to include the manual override as described above, as a known way to control fluid flow through an aspiration line in the case of an abnormal event requiring immediate shutdown of a normal pumping process, as taught in Teigen, with a reasonable expectation of success.
Claims 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson, in view of Sorensen or Barwick, further in view of Look et al (U.S. 10,702,292 B2, hereinafter “Look”).
Regarding claims 34-36, it is noted that Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising an air leak sensor in communication with the vacuum controller and/or the regulator, the air leak sensor configured to detect air flow through the aspiration tubing and to send a leak signal to the vacuum controller and/or the regulator upon detection of air through the aspiration tubing;
the aspiration control system of claim 34, wherein the vacuum controller and/or the regulator are configured to decrease the vacuum pressure within the vacuum line while the air leak is addressed;
and the aspiration control system of claim 35, wherein detection of air leaks and/or responding to detection of air leaks is delayed during a vacuum initialization period.
Look discloses a system for real time monitoring of an aspiration system, and discloses that the method includes detecting air within aspiration tubing and sending a leak signal to a controller (see col. 11, line 38 to col. 12, line 5 disclosing that when an air leak in the aspiration tubing is detected, a signal is sent to a controller to generate an appropriate alert). Further, as shown in Fig. 5C, vacuum is initiated before the leak is detected, indicating a delay during initialization of vacuum before detection occurs (specifically, Fig. 5C shows a breach 87, such as a leak, occurring after the initialization of vacuum indicated by slope 99). Further, the system disables the vacuum source while the leak is being addressed (see col. 26, lines 19-26).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Larsson, in view of Sorensen or Barwick, as taught in Look, in order to detect air within the aspiration tubing and send a leak signal to the regulator, the pump, or to the vacuum controller, in order to determine whether a breach in the system has occurred and to properly respond if necessary to resolve the breach after the initialization of vacuum (see Look at col. 11, lines 38-51 and lines 65-67; see also Fig. 5C). Doing so would have resulted in a more stable, effective method of clot removal with a reasonable expectation of success.
Regarding claim 37, Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising an indicator in communication with the sensor, the indicator configured to inform a user of a characteristic of the flow parameter.
Look discloses a system for real time monitoring of an aspiration system, and discloses that the system includes various visual indicators, such as LEDs, or visual message displays, in order to indicate characteristics of flow parameters such as indications of thrombus, clogs, system leaks, loss of vacuum, etc. (see col. 15, lines 13-27).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Larsson, in view of Sorensen or Barwick, as taught in Look, in order to give real time awareness to users performing aspiration procedures, such as the removal of thrombus via an aspiration system. One skilled in the art would have recognized that by knowing the real time condition of the aspiration system via indicators, a user would have been able to immediately make changes to the procedure in order to optimize results, increase safety for the patient and/or medical personnel or reduce costs and/or procedure time (see Look at col. 15, lines 13-35).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Larsson, in view of Sorensen or Barwick, further in view of Lockhart et al (U.S. Pub. 2010/0204672 A1, hereinafter “Lockhart”).
Regarding claim 38, Larsson, in view of Sorensen or Barwick, does not appear to disclose the aspiration control system of claim 22, further comprising an aspiration catheter and a thrombectomy device configured for axial movement within the aspiration catheter.
Lockhart discloses a system for removing a thrombus material from the body in which a thrombus retrieval device 16 (Fig. 1) is placed within the vasculature of a subject through an aspiration catheter 34 (Fig. 1).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Larsson, in view of Sorensen or Barwick, to position a thrombus retrieval device within the vascular system of the subject through the aspiration catheter, as taught in Lockhart, in order to perform various advantageous functions including drawing the thrombus material closer to the aspiration catheter (see Lockhart para [0039]) and to break up the thrombus material before aspiration (para [0039]).
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 07/10/2026
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