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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numeral “47” in Fig. 1 and Fig. 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 6 and 19 are objected to because of the following informalities:
In claim 6, there is an instance of rough grammar in line 2 at “is configured sense” (wherein a minor amendment such as “is configured to sense” will moot this objection);
In claim 19, there is an instance of rough grammar in lines 1-2 at “wherein at least one nonintrusive sensor” (wherein a minor amendment such as “wherein the at least one nonintrusive sensor” will moot this objection).
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 10 is 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.
Claim 10 recites the limitation "the aspiration pump" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 10-15, 18, 24 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Raney et al. (US 2017/0151092) in view of Lobdell (US 2001/0031976).
Raney discloses (see Figs. 1-2A) an automatic aspiration adjustment system comprising the following claim limitations:
(claim 1) An adaptive flow rate control system for a surgical device, comprising: at least one nonintrusive sensor configured to be positioned on an aspiration conduit extending downstream from a handheld surgical device; and wherein the at least one nonintrusive sensor provides data to at least one controller of the adaptive flow rate control system thereby enabling the at least one controller to control operation of at least one component of the adaptive flow rate control system based, at least in part, on the data provided by the at least one nonintrusive sensor; at least one device controller (102) configured to (i.e., capable of) control at least one handheld surgical device (110, Fig. 2A) ([0037]-[0038]; host 102 expressly controls one or more pumps (e.g. 54), at least one processor board, and an additional controller for controlling aspiration and flow rate/vacuum pressure at an aspiration port in a distal tip of the handheld surgical device 110 based on data from sensor 64; [0041]-[0042]);
(claim 2) wherein the at least one component of the adaptive flow rate control system (100) comprises at least one aspiration system controller configured to (i.e. capable of) control an aspiration pump ([0037]-[0038]; host 102 expressly controls one or more pumps (e.g. 54), at least one processor board, and an additional controller for controlling aspiration and flow rate from a surgical site; [0041]-[0042]);
(claim 10) further comprising a user input receiver (e.g. a foot pedal and/or input touchscreen expressly disclosed; [0035]-[0036]; [0038]; [0083]) configured to (i.e. capable of) receive at least one input from a user to actuate a clog removal function whereby the adaptive flow rate control system (100) is configured to (i.e. capable of) actuate the aspiration pump to increase in speed to create a greater vacuum (see 1020, Fig. 10A; [0083]; system 100 is expressly capable of and is expressly disclosed to receive user input via a foot pedal for increasing pump aspiration rate);
(claim 11) further comprising an interface housing (16A, Fig. 2) configured to (i.e. capable of) house the nonintrusive sensor (64) (as shown in Fig. 2; [0040]-[0041]) and to receive data via wireless communications from the at least one nonintrusive sensor (64) ([0035]-[0038]; [0042]; all components expressly may include wireless connections to the host 102 of the system 100);
(claim 12) further comprising a wireless communication system ([0035]-[0038]; [0042]; all components expressly may include wireless connections to the host 102 of the system 100) configured to (i.e. capable of) receive data from the at least one nonintrusive sensor (64) and transmit the data to the at least one controller (102) configured to (i.e. capable of) control operation of at least one component (e.g. 54) of the adaptive flow rate control system (100) ([0037]-[0038]; host 102 expressly controls one or more pumps (e.g. 54), at least one processor board, and an additional controller for controlling aspiration and flow rate from a surgical site; [0041]-[0042]);
(claim 13) A surgical device system (100, Fig. 1) comprising a handheld surgical device (110, Fig. 2A) with a working element ([0037]; [0041]; working distal tip expressly disclosed); an aspiration system comprising an aspiration pump (54, Fig. 2A), aspiration system controller (102, Fig. 1) ([0035]-[0041]; host controller expressly engaged with cassette 16A for controlling aspiration) and an aspiration conduit (52, Fig. 2A) extending from the handheld surgical device (110) to the aspiration pump (54) (as shown in Figs. 1-2A); an adaptive flow rate control system (50, Fig. 2A) comprising at least one nonintrusive sensor (64, Fig. 2A) positioned on the aspiration conduit (52) downstream from the working element of the handheld surgical device (110) (as expressly shown in Fig. 2A); and wherein the at least one nonintrusive sensor (64) is in communication with the aspiration system controller (102) that controls operation of the aspiration pump (54) such that the aspiration pump (54) is configured to (i.e. capable of) control suction within the aspiration conduit (52) via pump operation based, at least in part, on data provided by the at least one nonintrusive sensor (64) ([0035]-[0042]; vacuum sensor 64 provides data to controller 102 for controlling aspiration and helping determine appropriate flow rate thereby allowing the system to detect and adjust for temporary occlusion in the handpiece);
(claim 14) wherein the at least one nonintrusive sensor (64) is in communication with at least one device controller that controls the handheld surgical device (110) such that the at least one device controller is configured to (i.e. capable of) control operation of the at least one handheld surgical device (110) based, at least in part, on data provided by the at least one nonintrusive sensor (64) ([0037]-[0038]; host 102 expressly controls one or more pumps (e.g. 54), at least one processor board, and an additional controller for controlling aspiration and flow rate/vacuum pressure at an aspiration port in a distal tip of the handheld surgical device 110 based on data from sensor 64; [0041]-[0042]);
(claim 15) wherein the at least one nonintrusive sensor (64) is positioned on the aspiration conduit (52) between the handheld surgical device (110) and the aspiration pump (54) (as expressly shown in Fig. 2A);
(claim 18) wherein the at least one nonintrusive sensor (64) is positioned at a potential blockage location in the aspiration conduit (e.g. 52) to enable the adaptive flow rate control system to detect a clog in the aspiration conduit (52) (as shown in Fig. 2A; [0042]; sensor 64 disposed in the aspiration conduit path at a potential clog location and expressly is used to detect occlusions therein);
(claim 24) wherein the adaptive flow rate control system further comprises a user input receiver (e.g. a foot pedal and/or input touchscreen expressly disclosed; [0035]-[0036]; [0038]; [0083]) configured to (i.e. capable of) receive at least one input from a user to actuate a clog removal function whereby the adaptive flow rate control system (100) is configured to (i.e. capable of) actuate the aspiration pump to increase in speed to create a greater vacuum (see 1020, Fig. 10A; [0083]; system 100 is expressly capable of and is expressly disclosed to receive user input via a foot pedal for increasing pump aspiration rate);
(claim 26) wherein the adaptive flow rate control system further comprises an interface housing (16A, Fig. 2) configured to (i.e. capable of) house the nonintrusive sensor (64) (as shown in Fig. 2; [0040]-[0041]) and to receive data via wireless communications from the at least one nonintrusive sensor (64) ([0035]-[0038]; [0042]; all components expressly may include wireless connections to the host 102 of the system 100);
(claim 27) wherein the adaptive flow rate control system further comprises a wireless communication system ([0035]-[0038]; [0042]; all components expressly may include wireless connections to the host 102 of the system 100) configured to (i.e., capable of) receive data from the at least one nonintrusive sensor (64) and transmit the data to at least one surgical console ([0078]; host 102 expressly further includes a console) configured to (i.e., capable of) control operation of at least one component of the system ([0038]; [0041]-[0042]; [0078]; various input means are disclosed for instrument host 102 with the host further controlling all components of the aspiration flow network); and
(claim 28) wherein the adaptive flow rate control system further comprises a data bus ([0038]; data bus expressly disclosed) placing the at least one nonintrusive sensor (64) in communication with the aspiration system controller (102) ([0037]-[0038]; [0042]; instrument host/controller 102 expressly controls aspiration via pumps with the sensor 64 disclosed as part of the overall aspiration flow network).
Raney, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for wherein the adaptive flow rate control system is in communication with the at least one device controller to close a cutting window at a working element of the handheld surgical device to further increase the vacuum within the aspiration conduit to remove material.
However, Lobdell teaches (see Figs. 1-2 and 6-7) a similar medical aspiration system (50, Figs. 6) comprising an adaptive flow rate control system (52/68, Fig. 6) is in communication with the at least one device controller (54, Fig. 6) to close a cutting window (16, Figs. 1-2 and 7) at a working element (10, Figs. 1-2 and 7) of the handheld surgical device to further increase the vacuum within the aspiration conduit (at 22, Figs. 1-2 and 7) to remove material (see Abstract; [0009]-[0010]; [0028]-[0029]; closure of port 16 via received sensor data performed to increase vacuum and remove cut material within the aspiration conduit) in order to beneficially provide a working element that spends more time removing and aspirating tissue away from a treatment site as compared to conventional working elements and further is capable of sensing an occlusion (see Abstract; [0007]-[0010]; [0028]-[0029]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney to have the adaptive flow rate control system is in communication with the at least one device controller to close a cutting window at a working element of the handheld surgical device to further increase the vacuum within the aspiration conduit to remove material in order to beneficially provide a working element that spends more time removing and aspirating tissue away from a treatment site as compared to conventional working elements and further is capable of sensing an occlusion, as taught by Lobdell.
Claim(s) 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claims 1 and 13 above, and further in view of Smith et al. (US 2016/0331876).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the at least one nonintrusive sensor being configured to snap onto an outer surface of the aspiration conduit.
However, Smith teaches a similar medical suction system comprising at least one nonintrusive sensor (130, Fig. 4) being configured to (i.e. capable of) snap onto an outer surface of the aspiration conduit (126, Fig. 4) ([0066]; snap fit expressly taught) in order to beneficially provide a snap fit sensor that is both adjustable and a releasable thereby allowing for repositioning, replacement, maintenance, and/or sterilization of each sensor ([0066]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have at least one nonintrusive sensor being configured to snap onto an outer surface of the aspiration conduit in order to beneficially provide a snap fit sensor that is both adjustable and a releasable thereby allowing for repositioning, replacement, maintenance, and/or sterilization of each sensor, as taught by Smith.
Claim(s) 4-5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claims 1 and 13 above, and further in view of Steg, Jr. et al. (US 5,411,472).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the at least one nonintrusive sensor being configured to sense fluid density and velocity within the aspiration conduit.
However, Steg teaches a similar medical suction system comprising at least one nonintrusive sensor being configured to sense fluid density (col. 4, lines 36-68; fluid density expressly sensed) and velocity (col. 3, line 29-col. 4, line 10; low flow velocity expressly sensed and maintained) within the aspiration conduit in order to beneficially reduce damage and provide low blood trauma to during aspiration and suction removal from a treatment site thereby allowing for return to the patient if desired (see Abstract; col. 1, line 50-col. 2, line 6; col. 2, lines 34-43). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have at least one nonintrusive sensor being configured to sense fluid density and velocity within the aspiration conduit in order to beneficially reduce damage and provide low blood trauma to during aspiration and suction removal from a treatment site thereby allowing for return to the patient if desired, as taught by Steg.
Claim(s) 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claims 1 and 13 above, and further in view of Kucklick (US 2007/0060915).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the at least one nonintrusive sensor being configured to sense temperature of a material flowing through the aspiration conduit.
However, Kucklick teaches a similar medical suction system comprising at least one nonintrusive sensor (8) being configured to (i.e. capable of) sense temperature of a material flowing through the aspiration conduit ([0027]; sensing the temperature of the fluid outflow from the surgical site expressly disclosed) in order to beneficially provide a temperature warning when temperatures exceed a predetermined safe threshold to prevent tissue damage ([0006]; [0033]-[0035]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have at least one nonintrusive sensor being configured to sense temperature of a material flowing through the aspiration conduit in order to beneficially provide a temperature warning when temperatures exceed a predetermined safe threshold to prevent tissue damage, as taught by Kucklick.
Claim(s) 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claims 1 and 13 above, and further in view of Fanton et al. (US 2007/0100276).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for a clog tracking module configured to track a location of a clog within the aspiration conduit, wherein the clog tracking module comprises a plurality of nonintrusive sensors configured to be positioned along the aspiration conduit for tracking a location of a clog within the aspiration conduit.
However, Fanton teaches a similar medical suction system comprising a clog tracking module configured to (i.e. capable of) track a location of a clog within the aspiration conduit, wherein the clog tracking module comprises a plurality of nonintrusive sensors configured to (i.e. capable of) be positioned along the aspiration conduit for tracking a location of a clog within the aspiration conduit ([0150]; [0226]; a plurality of sensors are taught to each directly be able to detect a tissue obstruction and/or indirectly detect an obstruction location via a localized reduction in flow at a respective sensor likely associated with an obstruction wherein the sensor module automatically actuates an obstruction removal action) in order to beneficially detect an obstruction or clog and then automatically actuate a means for removing the obstruction or clog sensed within the aspiration lines ([0150]; [0226]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have a clog tracking module configured to track a location of a clog within the aspiration conduit, wherein the clog tracking module comprises a plurality of nonintrusive sensors configured to be positioned along the aspiration conduit for tracking a location of a clog within the aspiration conduit in order to beneficially detect an obstruction or clog and then automatically actuate a means for removing the obstruction or clog sensed within the aspiration lines, as taught by Fanton.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claim 13 above, and further in view of Bourne (US 2017/0367885).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the at least one nonintrusive sensor being positioned within the handheld surgical device.
However, Bourne teaches a similar medical aspiration system (100, Figs. 1-2) comprising at least one nonintrusive sensor (392, Fig. 3) being positioned within the handheld surgical device (112, Figs. 1 and 3) ([0038]; [0041]-[0042]; sensor 392 expressly located within aspiration conduit 340 of handpiece 112) in order to beneficially provide for early detection of occlusion breaks, and therefore, may reduce and/or counter the change or impact of occlusion surges resulting in a more consistent and predictable procedure by reducing the effects of pressure deviations that occur with post-occlusion surges ([0038]-[0042]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have at least one nonintrusive sensor being positioned within the handheld surgical device in order to beneficially provide for early detection of occlusion breaks, and therefore, may reduce and/or counter the change or impact of occlusion surges resulting in a more consistent and predictable procedure by reducing the effects of pressure deviations that occur with post-occlusion surges, as taught by Bourne.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claim 13 above, and further in view of Bates et al. (US 2003/0187390).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the adaptive flow rate control system further comprising a roller valve positioned in the handheld surgical device enabling a user to control aspiration through the aspiration conduit via rotational movement of the roller valve and wherein the adaptive flow rate control system is configured to sense the aspiration reduction caused by movement of the roller valve and send a signal to the aspiration pump to increase in speed to create a greater vacuum.
However, Bates teaches (see Figs. 3A-4C) a similar medical aspiration system (100) comprising a roller valve (129) positioned in the handheld surgical device (110) enabling a user to control aspiration through the aspiration conduit (136) via rotational movement of the roller valve (129) ([0042]-[0043]; roller valve 129 expressly controls fluid flow within lumen 136/158) and wherein the adaptive flow rate control system is configured to (i.e. capable of) sense the aspiration reduction caused by movement of the roller valve (129) and send a signal to the aspiration pump (54 of the device of Raney) to increase in speed to create a greater vacuum (as set forth above in claim 11, the device of Raney (see 1020, Fig. 10A; [0083]) provides a system 100 expressly capable of and is expressly disclosed to receive user input via a foot pedal for increasing pump aspiration rate and/or automatically increase pump aspiration rate in response to an occlusion signal from sensors 64) in order to beneficially provide the ability to selectively inhibit fluid transfer as desired and thereby preventing “back-bleed” from occurring when a proximal port is open ([0042]-[0043]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have the adaptive flow rate control system further comprising a roller valve positioned in the handheld surgical device enabling a user to control aspiration through the aspiration conduit via rotational movement of the roller valve and wherein the adaptive flow rate control system is configured to sense the aspiration reduction caused by movement of the roller valve and send a signal to the aspiration pump to increase in speed to create a greater vacuum in order to beneficially provide the ability to selectively inhibit fluid transfer as desired and thereby preventing “back-bleed” from occurring when a proximal port is open, as taught by Bates.
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Raney in view of Lobdell as applied to claim 13 above, and further in view of Culbert et al. (US 2020/0289722).
Raney in view of Lobdell, as applied above, discloses an automatic aspiration adjustment system comprising all the limitations of the claim except for the at least one nonintrusive sensor comprising a camera configured to capture images of matter flowing within the aspiration conduit.
However, Culbert teaches (see Figs. 3A-4C) a similar medical aspiration system (100) wherein the at least one nonintrusive sensor comprises a camera configured to (i.e. capable of) capture images of matter flowing within the aspiration conduit (1438, Fig. 37) ([0205]; camera expressly disclosed) in order to beneficially allow aspirated material to be identified and/or assessed (e.g. quantity and/or physical state) in real-time during aspiration ([0205]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Raney in view of Lobdell to have the at least one nonintrusive sensor comprising a camera configured to capture images of matter flowing within the aspiration conduit in order to beneficially allow aspirated material to be identified and/or assessed (e.g. quantity and/or physical state) in real-time during aspiration, as taught by Culbert.
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.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,137,960. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
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U.S. Patent No. 12,137,960, as applied above, claims a surgical device system comprising all the limitations of the claim except for wherein the adaptive flow rate control system is in communication with the at least one device controller to close a cutting window at a working element of the handheld surgical device to further increase the vacuum within the aspiration conduit to remove material.
However, Lobdell teaches (see Figs. 1-2 and 6-7) a similar medical aspiration system (50, Figs. 6) comprising an adaptive flow rate control system (52/68, Fig. 6) is in communication with the at least one device controller (54, Fig. 6) to close a cutting window (16, Figs. 1-2 and 7) at a working element (10, Figs. 1-2 and 7) of the handheld surgical device to further increase the vacuum within the aspiration conduit (at 22, Figs. 1-2 and 7) to remove material (see Abstract; [0009]-[0010]; [0028]-[0029]; closure of port 16 via received sensor data performed to increase vacuum and remove cut material within the aspiration conduit) in order to beneficially provide a working element that spends more time removing and aspirating tissue away from a treatment site as compared to conventional working elements and further is capable of sensing an occlusion (see Abstract; [0007]-[0010]; [0028]-[0029]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of U.S. Patent No. 12,137,960 to have the adaptive flow rate control system is in communication with the at least one device controller to close a cutting window at a working element of the handheld surgical device to further increase the vacuum within the aspiration conduit to remove material in order to beneficially provide a working element that spends more time removing and aspirating tissue away from a treatment site as compared to conventional working elements and further is capable of sensing an occlusion, as taught by Lobdell.
Allowable Subject Matter
Claims 8-9, 19 and 22-23 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. It is noted that claims 8-9, 19 and 22-23 remain subject to double patenting rejections which must be resolved before any of these claims can be rewritten into proper condition for allowance.
The following is an examiner’s statement of reasons for acknowledging allowable subject matter: the art of record does not teach or render obvious a system as claimed that includes, in combination with the claim(s) as a whole, a clog prediction module to predict a future location of a clog based at least in part on data from the at least one nonintrusive sensor and/or wherein the at least one nonintrusive sensor is positioned upstream from a potential trouble spot in the aspiration conduit to enable the adaptive flow rate control system to detect a bolus before the bolus stops flow through the aspiration conduit.
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Conclusion
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771