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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2026. As directed by the amendment: claims 1, 7, 9, and 12 have been amended, claims 2 and 10-11 have been cancelled, and no new claims have been added. Thus, claims 1, 3, 7, 9, and 12-13 are presently pending in this application. Applicant’s amendments to the claims have overcome each and every 112 rejection set forth in the Non-Final Office Action mailed on 03/23/2026.
Response to Arguments
Applicant’s arguments, see p.13, lines 18-19 of “Remarks”, filed 06/23/2026, with respect to the 103 rejection of claim 1 have been fully considered and are persuasive. The 103 rejection of claim 1 of 03/23/2026 has been withdrawn.
Applicant's arguments regarding the 103 rejection of claim 9, filed 06/23/2026 have been fully considered but they are not persuasive.
In response to applicant's argument on p.12, lines 16-22 of “Remarks” that the examiner's conclusion of obviousness is based upon improper hindsight reasoning which teaches away from the claimed architecture, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Examiner further notes that applicant’s argument that Hamel teaches the opposite of integrating a second, distinct, portable pump into the device, it is noted that the features upon which applicant relies (i.e. second, distinct, portable pump) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim requires an instrument that comprises two controlled negative-pressure pumps of different pump types having different pumping mechanisms wherein the specific pump types are claimed. Hamel discloses two negative-pressure pumps (outflow of 50 and 56), wherein the first negative-pressure pump (outflow of 50) is a part of a peristaltic pump system type or mechanism of the second negative-pressure pump (wall suction unit 56) is not disclosed. Examiner emphasizes that the pumping mechanism of the second negative-pressure pump is not disclosed, and thus there is no evidence that Hamel teaches away from the claimed architecture. Thus, examiner notes Hamel is properly modified by Janardhan to teach the specific pumping mechanism of the second negative-pressure pump and modifying a type of suction pump to be a diaphragm pump is an obvious modification as the diaphragm pump of Janardhan performs the same function as the suction wall pump (56) of Hamel and is used in the same type of procedure.
In response to applicant’s arguments on p.13, lines 4-14 that Haischmann, Chandler, and Janardhan fails to appreciate the importance of the “start-up dynamics” and a person of ordinary skill in the art would not have been motivated to combined these references because they would not have predicted this specific, advantageous interplay of their different dynamic properties, examiner notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Further, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the primary reference Hamel discloses a distributed, dual-pump architecture comprising the liquid supply pump (inflow of 50), the controlled first negative-pressure pump (outflow of 50) being a roller-wheel pump, a controlled second-negative pressure pump (56, see para. 0031-0032), and a first (54) and second medical instrument (44) each with their own suction lines (52, 57, respectively) connected to the respective first and second negative-pressure pumps (see para. 0031-0032). The modifications made in view of Haischmann, Chandler, and Janardhan would have been obvious to one of ordinary skill in the art and are motivated modifications as discussed below in the rejection of claim 9. As stated above, the claimed invention does not need to be expressly suggested in any one or all of the references, and thus Haischmann, Chandler, and Janardhan do not need to expressly suggest the claim invention individually. Haischmann, Chandler, and Janardhan modify the irrigation and dual-aspiration system of Hamel to substitute one suction pump type (Haischmann), modify the irrigation pump operating parameters (Chandler), and incorporate a waste container and modify the suction pump operating parameters (Janardhan) to thus disclose the claimed invention. Examiner further notes that a recitation of the intended use of the claimed invention (e.g. start-up dynamics) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Thus, if the prior art structure is capable of performing the intended use that is claimed, then it meets the claim limitation. Thus, because Hamel in view of Haischmann in view of Chandler in view of Janardhan disclose the structure and functional operating parameters of the claimed pumps, and specifically Hamel discloses the limitation “operate the roller wheel pump continuously during a procedure and to operate the controlled second negative-pressure pump only as needed in response to an activation of the second medical instrument”, the claim limitation is met. Hamel discloses that the roller wheel pump (inflow pump of 50) operates to provide irrigation flow continuously to maintain clear imaging while the suction flow from the second negative-pressure suction pump (56) is only operated as needed for use of the cutting tool (42, see para. 0079-0080).
Examiner suggests removing the new matter limitations below (see 112a rejection below for suggested amendment) and specifying that the first suction line, second suction line, and auxiliary line are discrete lines in claim 9 in a similar manner as the limitations of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 7, 9, and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “a controller communicatively coupled to the controlled first negative-pressure pump and the controlled second negative-pressure pump, the controller being configured to operate the controlled first negative-pressure pump continuously during a procedure and to operate the controller second negative-pressure pump only as needed in response to an activation of the second medical instrument” is new matter. The disclosure does not have support for the medical instrument comprising a controller. The specification discloses that the pumps and various lines are “controllable” but there is not structure disclosed such as a “controller” for performing this function. The specification nor the drawing provide support for this limitation. Given that there is no support in the disclosure for a controller, this limitation is new matter.
Regarding claim 1, the limitation “the controller being configured… to operate the controller second negative-pressure pump only as needed in response to an activation of the second medical instrument” in lines 29-30 is new matter. The disclosure does not have support for the second negative-pressure pump operation only as needed in response to an activation of the second medical instrument. The specification discloses the following two excerpts:
p.9, lines 32-34 – “The medical instrument with high flow resistance is disconnected through a valve, and only upon activation, the suction line is opened there.”
p.10, lines 22-25 – “The procedure of gripping around can be promoted by activation of the suction line with an additional aspiration pulse created by the pump unit generating a negative pressure, so that by the additional aspiration process, the stone is positioned in the instrument.”
Neither of these excerpts provide support for the claim limitation as the first excerpt does not specify whether the medical instrument or the valve is being activated nor that this triggers operation of the second negative-pressure pump only that the suction line is opened. The second excerpt only specifies that the second suction line is activated to position the stone within the instrument but does not provide support for the claim limitation. The specification nor the drawing provide support for this limitation. Given that there is no support in the disclosure for the limitation, it is new matter.
Regarding claim 9, the limitation “a controller communicatively coupled to the controlled first negative-pressure pump and the controlled second negative-pressure pump, the controller being configured to operate the roller wheel pump continuously during a procedure and to operate the controlled second negative-pressure pump only as needed in response to an activation of the second medical instrument” is new matter for the above discussed reasons.
Regarding claim 9, the limitation “the controller being configured… to operate the controller second negative-pressure pump only as needed in response to an activation of the second medical instrument” in lines 26-28 is new matter for the above discussed reasons.
Examiner suggests amending claims 1 and 9 to recite “ (ix) the roller wheel pump configured to operate continuously during a procedure and the second negative-pressure pump configured to operate only as needed in response to activation [or “opening”] of the second suction line”
Regarding claims 3, 7, and 12-13, these claims are rejected due to their dependency upon a rejected base claim.
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.
Claim(s) 9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hamel et al. (U.S Patent Pub. No. 2011/0237880 A1, “Hamel”) in view of Haischmann et al. (U.S Patent Pub. No. 2004/0133149 A1, “Haischmann”) in view of Chandler et al. (U.S Patent No. 5830180, “Chandler”) in view of Janardhan et al. (U.S Patent Pub. No. 20180368965 A1, “Janardhan”).
Regarding claim 9, Hamel discloses the limitations of (Claim 9) a medical instrument (30) for flushing cavities in minimally invasive surgery (see at least Fig. 2 and Abstract and para. 0030 – surgical control system 30 is a fluid management system for managing a surgical site during an endoscopic surgery), comprising
a storage container (reservoir of 50) for a flushing liquid (see Fig. 2 and para. 0035 – pump system 50 comprises a fluid storage means for supplying the irrigation fluid),
a supply line (76) for supplying the flushing liquid into a body cavity (80, see Fig. 2 and para. 0035 – irrigation tubing 76 connects pump system 50 to surgical site 80 for supplying the irrigation fluid),
a controlled pump (inflow of 50) for pumping the flushing liquid from the storage container (reservoir of 50) through the supply line (76) to the body cavity (80, see Fig. 2 and para. 0035 – pump system 50 comprises an inflow mechanism being interpreted as the controlled pump which pumps irrigation fluid form the fluid storage means within the pump system 50 through irrigation tubing 76 to the surgical site 80),
a controlled first negative-pressure pump (outflow of 50), the controlled first negative-pressure pump (outflow of 50, see Fig. 2 and para. 0031 – pump system 50 comprises a suction mechanism being interpreted as the first negative pressure pump); the controlled first negative-pressure pump (outflow of 50) being a roller wheel pump (see Fig. 2 and para. 0031 – pump system 50 comprises a suction mechanism being interpreted as the first negative pressure pump, pump system 50 is a peristaltic pump);
a controlled second negative-pressure pump (56, see Fig. 2 and para. 0032 – system 30 additionally comprises suction unit 56 interpreted as the second negative-pressure pump),
a first medical instrument (54) with a first suction line (52), which is operatively associated with the controlled first-negative pressure pump (outflow of 50, see Fig. 2 and para. 0031 – pump system 50 comprises a suction mechanism that is attached to suction line 52 for providing suction to cannula 54),
a second medical instrument (44) with a second suction line (57), which is operatively associated with the controlled second negative-pressure pump (56, see Fig. 2 and para. 0032 – wall suction unit 56 is attached to suction tubing 57 for providing suction to handpiece 44), and
a controller (34 in Fig. 2) communicatively coupled to the controlled first negative-pressure pump (outflow of 50) and the controlled second negative-pressure pump (56, see Fig. 2 and para. 0031-0032 – pump system 50 communicates with system controller 34, valve of wall suction unit 56 is automatically controlled by controller 34), the controller (34) being configured to operate the roller wheel pump continuously during a procedure and to operate the controlled second negative-pressure pump (56) is only running as needed based in response to an activation of the second medical instrument (44, examiner notes this limitation is being interpreted as the structure of the roller wheel pump must be capable of being configured to operate continuously and the controlled second negative-pressure pump is capable of being configured to run only intermittently upon activation of the second medical instrument, see para. 0073 – system controller 34 operates the inflow pump of the pump system 50 to provide flow through the irrigation tubing 76 continuously throughout the procedure to maintain clear imaging, para. 0079-0080 – controller 34 automatically controls operation of the cutting tool 42 and suction flow to the cutting tool 42 from the wall suction unit 56 as needed for providing clear imaging and is thus capable of being configured to run the wall suction unit 56 upon activation of the cutting tool 42).
However, Hamel fails to disclose the limitations of (Claim 9) the controlled pump adapted and configured for pumping the flushing liquid at a flow rate of 2.5 l/min and a pressure of 300 mmHg, the controlled first negative-pressure pump being a roller wheel pump and adapted and configured for generating a first negative pressure of 450 mm Hg and a first aspiration flow rate of 1.5 l/min, the controlled second negative-pressure pump being either a Venturi pump or a diaphragm pump, wherein the controlled first and second negative-pressure pumps are different pump types having different pumping mechanism, the controlled second negative-pressure pump is adapted and configured for generating a second negative pressure of 450 mm Hg and a second aspiration flow rate of 1.5 l/min, a waste container connected to the first suction line and the second suction line, and wherein the waste container is connected through an auxiliary line to the controlled second negative-pressure pump, the first suction line extends from the first medical instrument to the waste container; and the second suction line extends from the second medical instrument to the waste container.
Haischmann teaches the limitations of (Claim 9) a waste container connected to the first suction line (8) and the second suction line (10, see Fig. 1 and. para. 0013 and 0027 – drainage line 8 and suction line 10 are connected to a collection vessel as illustrated), and wherein the waste container is connected through an auxiliary line to the controlled second negative-pressure pump (11); the first suction line (10) extends from the first medical instrument (9) to the waste container and the second suction line (8) extends from the second medical instrument (7) to the waste container (see Fig. 1 and. para. 0013 and 0027 – suction pump 11 is connected through a separate line to the illustrated collection vessel interpreted as the auxiliary line, drainage line 8 extends from cannula 7 indirectly to the collection vessel, suction line 10 extends from instrument 9 indirectly to the collection vessel). Examiner notes the two suction lines 8 and 10 and their respective medical instruments are operatively associated with the same suction pump 11, but Haischmann teaches the concept of any line/instrument associated with a suction pump also being connected with a waste container through an auxiliary line.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second suction lines taught by Hamel to be connected to a waste container through an auxiliary line as taught by Haischmann. The motivation for this modification is Haischmann teaches suction lines that are provided a waste container such that excess fluids and debris can be removed from the surgical site to enhance visibility (see para. 0021 and 0027).
Chandler discloses an irrigation and suction system for controlling the flow of fluid during an arthroscopic surgery in a joint body cavity (see Col.1, lines 16-35). Chandler teaches (Claim 9) the controlled pump (40) adapted and configured for pumping the fluid at a fluid flow rate of 2 l/min and a pressure of 300 mm Hg (see Fig. 1 and Col.6, lines 3-20 – the fluid management apparatus of Fig. 1 comprises a fluid supply pump 40 in the form of a roller pump, see Col.17, lines 3-32 – the flow rates of the system including that of the pump 40 may be set to a range of 0-2000 ml/min which converts to 0-2 L/min and the fluid supply may produces pressure ranges within the supply conduit 48 attached to pump 40 of up to 500 mm Hg), the controlled first negative-pressure pump (72) being a roller wheel pump and adapted and configured for generating a first negative pressure of 450 mm Hg and a first aspiration flow rate of 1.5 l/min (see Fig. 1 and Col. 6, lines 54-65 – the apparatus of Fig. 1 further comprises a vacuum pump 72 in the form of a roller pump, see Col.17, lines 3-32 – the flow rates of the system including that of the pump 72 may be set to a range of 0-2000 ml/min which converts to 0-2 L/min and the vacuum pressure produced by pump 72 may range between 220-350 mm Hg or be greater).
Examiner notes applicant places no criticality on the disclosed pressure and flow rate only stating for the irrigation pump “a pump is used that can transfer a fluid flow of 2.5 l/min and can create a pressure of 300 mm Hg” (see p.5, lines 13-18) and for the suction pump “it is necessary that the pump used in the aspiration device can generate a negative pressure of 450 mm Hg and a liquid flow of 1.5 l/min” (see p.6, lines 3-7). Examiner further notes that the controlled pump and first suction pump are functionally limited by the flow rates and pressures, and thus the prior art must be capable of being configured to generate the disclosed flow rates and pressures. While Chandler fails to explicitly disclose a controlled pump adapted and configured for pumping flow at a fluid flow rate of 2.5 l/min and a controlled first negative-pressure pump adapted and configured for generating a first negative pressure of 450 mm Hg, one of ordinary skill in the art could have combined the system of modified Hamel and the pump flow rates and pressures of Chandler by known methods to yield predictable results. Examiner notes the controlled pump and first suction pumps of modified Hamel and Chandler are both roller pumps used in arthroscopic procedures which are capable of being configured to generate the disclosed flow rates and pressures. The controlled pump of modified Hamel is being modified to generate a pressure of 300 mm Hg as disclosed in Chandler’s range of 40-500 mm Hg and a flow rate of 2.5 l/min as Chandler discloses a range of 0-2 l/min and it would have been obvious according to known methods for the controlled pump to generate a flow rate of 2.5 l/min. The suction pump of modified Hamel is being modified to generate an aspiration rate of 1.5 l/min as disclosed in Chandler’s range of 0-2 l/min and a negative pressure of 450 mm Hg as Chandler discloses a range between 220-350 mm Hg or greater values such that it would have been obvious according to known methods for the suction pump to generate a negative pressure of 450 mm Hg without deviating from the scope of Chandler (see Col.17, 11-32). Thus, one of ordinary skill in the art would have recognized that the results of the combination of modified Hamel in view of Chandler were predictable.
Janardhan discloses a suction pump that may be used in arthroscopic procedures. Janardhan teaches (Claim 9) the controlled second negative-pressure pump (12390) being either a Venturi pump or a diaphragm pump (see Fig. 27I-4 and para. 1065 and1068 – suction pump 12390 may be a diaphragm pump), the controlled second negative-pressure pump (12390) is adapted and configured for generating a second negative pressure of 450 mm Hg and a second aspiration flow rate of 1.5 l/min (see para. 1065 and 1068 – pump 12390 generates a suction which may be used in arthroscopic procedures, the suction pump 12390 may produce a maximum flow rate of between 0.25 L/min and 300 L/min with the rate 1.4 L/min explicitly recited and suction pressure between 0 mm Hg and -700 mm Hg with the pressures -400 mm Hg and -550 mm Hg explicitly recited).
While Janardhan fails to explicitly disclose a controlled second negative-pressure pump adapted and configured for generating a second negative pressure of 450 mm Hg and second aspiration flow rate of 1.5 l/min, Janardhan discloses a finite number of identified, predictable flow rates and pressures that are recognized solutions for being compatible for a particular medical indication or pathology (see para. 1068). One of ordinary skill in the art could have pursued these known potential solutions with a reasonable expectation of success. Examiner further notes that the suction pump of Janardhan is capable of being configured and adapted to generate the disclosed flow rate and negative pressure. Therefore, it would have been obvious for one of ordinary skill in the art to select a suction pressure of 450 mm Hg and an aspiration flow rate of 1.5 l/min from the finite number of identified, predictable pressures and flow rates recognized in Janardhan for being potential solutions to the recognized problems within the indicated medical procedures. Lastly, examine notes that applicant does not place criticality on the claimed pressure or flow rate only disclosing that “it is necessary that the pump used in the aspiration device can generate a negative pressure of 450 mm Hg and a liquid flow of 1.5 l/min” (see p.6, lines 3-7).
In combination, Hamel discloses controlled first negative pressure pump as a roller wheel pump and Janardhan teaches the controlled second negative-pressure pump being a diaphragm pump. Thus, in combination modified Hamel discloses (Claim 19 the controlled first and second negative-pressure pumps are different pump types having different pumping mechanisms.
Regarding claim 12, modified Hamel discloses the controlled second negative-pressure pump of claim 9, as discussed above. In modified Hamel, Hamel discloses (Claim 12) wherein the first medical instrument (55) is an endoscope (see para. 0031 – cannula 54 defines a portal into the surgical site 80 which is capable of being used for viewing the surgical site, examiner notes an endoscope is being interpreted as any cannula accessing the body used for viewing).
Regarding claim 13, modified Hamel discloses the endoscope of claim 12, as discussed above. In modified Hamel, Hamel discloses (Claim 13) wherein the procedure is a urological procedure and the controlled second negative-pressure pump (56) is adapted for creating an aspiration pulse (see Fig. 2 and para. 0079 – surgical system 30 is capable of being used during a urological procedure, cutting tool 42 attached to handpiece 44 and suction wall unit 56 may be pulsed with suction for cleaning or unclogging the tool).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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