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 .
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 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.
Response to Amendment
The Response filed December 9, 2025 has been entered. Claims 1-7, 9, 11, 13, 17, 19-24, 26, 28, 30-31, 33-35, 38-39, 41-42, and 47-48 are pending in the application with claims 20-24, 26, 28, 30-31, 33-35, and 38-39 being withdrawn from further consideration. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 8, 2025 was filed after the mailing date of the non-Final Office Action on June 9, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 11, 13, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (U.S. Patent Application Publication No. 20140276042; hereinafter “Smith”) in view of Lee et al. (U.S. Patent Application Publication No. 20200016331; hereinafter “Lee”).
Regarding claim 1, Smith discloses a method of operating a syringe pump (700; Fig. 7) comprising a syringe (710), a processor communicably coupled to the syringe (pump (700) is programmed to carry out fill and discharge routines (para. [0106]) executed by one or more processors (paras. [0056]-[0057]) microprocessor; para. [0056], [0062], [0082]), a first gear (820) and a second gear (810), the method comprising:
coupling the syringe pump (700) to a blood flow control device (740; angiography catheter (740) constitutes a “blood flow control device” as claimed because it is capable of controlling (i.e., directing influence over) blood flow by discharging fluid within a blood vessel of a patient at a rate, pressure, or speed that would alter normal blood flow within the blood vessel; paras. [0106]-[0107]);
determining, via the processor, a fluid transfer movement amount (e.g., amount piston (720) is moved to withdraw a desired amount of fluid into the syringe; para. [0100]);
moving, via the processor, at least one component of the syringe pump in a first direction the fluid transfer movement amount (e.g., to fill the syringe; para. [0106], see also paras. [0100]-[0102])); and
moving, via the processor, the at least one component of the syringe pump in a second direction opposite the first direction (e.g., to discharge the syringe; para. [0106]; see also para. [0100])).
The method of Smith discloses the invention substantially as claimed, except for determining a backlash compensation amount, moving the at least one component the backlash compensation amount and the fluid transfer movement amount, and moving the at least one component a biasing movement amount.
However, Smith discloses that precise control of the filling and ejection of fluids as a design feature of the method (para. [0105]). Smith also discloses that different amounts of fluid may be discharged by and filled into the pump during a procedure (para. [0106]).
Lee, a reference in the syringe pump field of endeavor, teaches
determining, via a processor, a backlash compensation amount (amount of “wind up” in syringe shaft movement within dead band (202); Fig. 16; para. [0101]);
moving, via the processor, the at least one component of the syringe pump a biasing movement amount (e.g., amount to account for initial motor movement; para. [0102]) in a second direction opposite the first direction to re-engage the first gear and the second gear (e.g., movement is to take into account initial motor movement during use; para. [0102])
in order to provide a syringe pump with improved precision in delivering a desired amount of fluid during use (para. [0102]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Smith to include
determining, via the processor, a backlash compensation amount;
moving, via the processor, at least one component of the syringe pump the backlash compensation amount and the fluid transfer movement amount in a first direction; and
moving, via the processor, the at least one component of the syringe pump a biasing movement amount in a second direction opposite the first direction to re-engage the first gear and the second gear
in view of Lee, in order to allow the syringe pump to more precisely deliver the desired amount of fluid to and from the pump as called for by a procedure.
Regarding claim 2, Lee discloses wherein an absolute value of the biasing movement amount is equal to an absolute value of the backlash compensation amount (as the wind up amount (para. [0101]) accounted for is the same as the initial motor movement accounted for in precision fluid delivery (para. [0102]).
Regarding claim 3, Smith discloses wherein moving the at least one component comprises moving a motor (830) operably coupled to the first gear (Fig. 8; paras. [0099]-[0100]).
Regarding claim 4, Sith discloses wherein moving the at least one component comprises moving the first gear (para. [0099]).
Regarding claim 5, Smith discloses wherein the first gear is a circular gear (820; Fig. 10; para. [0089]) and the second gear is a linear gear (810).
Regarding claim 6, Smith discloses wherein a plunger of the syringe comprises the linear gear (Figs. 8-10; para. [0098]).
Regarding claim 7, Smith discloses the syringe pump comprising a speed-controlling transmission box (840; Fig. 10) operably coupling a motor (830) to the first gear (820; para. [0099]), but is not explicitly disclosed with the pump including a gearbox.
Lee teaches providing a syringe pump with a gearbox (reducing gear train; para. [0079]) which determines the amount of movement in the pump components for fine control of the pumping volume (para. [0079]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the transmission box to include a gearbox operably coupling the motor to the first gear such that the backlash compensation amount is based at least in part on a gear ratio of the gearbox, in order to provide a user with greater control over the amount of pumped fluid to deliver the desired amount of fluid as called for by a procedure.
Regarding claim 11, Lee discloses wherein the method further comprises receiving, at the processor, a pressure measurement (154) indicative of a pressure inside the syringe and wherein the backlash compensation amount is based at least in part on the pressure measurement (para. [0101]).
Regarding claim 13, Smith discloses wherein the first direction is a fluid withdrawal direction (e.g., to fill the syringe; para. [0106], see also paras. [0100]-[0102])); and the second direction is a fluid injection direction (e.g., to discharge the syringe; para. [0106]; see also para. [0100])).
Regarding claim 17, Lee discloses the method further comprising determining a sum of the backlash compensation amount and the fluid transfer movement amount (para. [0101]), and wherein the sum is determined before moving the at least one component in the first direction (e.g., the sum is determined before movement to account for the “initial motor movement;” para. [0102]).
Regarding claim 19, Smith discloses wherein the syringe pump comprises a plunger (810; Figs. 8-10) including a linear gear (rack; para. [0098]), and a controller comprising a circular gear (820), wherein the circular gear is operably coupled to the linear gear (Fig. 10).
Additionally, the modified method teaches wherein moving the at least one component in the second direction re-engages the linear gear with the circular gear (e.g., during “wind up;” Lee para. [0101]) without materially moving the plunger (e.g., wind up movement of the circular gear to take-up a mechanical gap with the linear gear does not materially move the plunger because the gears would not be in contact during such wind up movement).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Lee, as applied to claim 7 above, and further in view of Cecchi et al. (U.S. Patent Application Publication No. 20060217670; hereinafter “Cecchi”).
Regarding claim 9, the modified method discloses the invention substantially as claimed, except for the gear ratio of the gearbox being between about 40:1 and about 150:1. However, Smith discloses that precise control of the filling and ejection of fluids as a design feature of the method (para. [0105]). Smith also discloses that different amounts of fluid may be discharged by and filled into the pump during a procedure (para. [0106]).
Cecchi, a reference in the medical syringe field of endeavor, teaches the gear ratio of a syringe plunger affects the amount of fluid moved dispensed by the syringe (para. [0030]). Cecchi further teaches that increasing the gear ratio reduces the effect of errors in fluid delivery with the movement of the plunger (para. [0030]).
Thus, a person having ordinary skill in the art would understand syringe gear ratio to be a result-effective variable for precisely dispensing a desired amount of fluid from the syringe.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the gearbox to have a gear ratio within the claimed range, as it involves merely selecting gears of appropriate size and number in the gearbox .
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gearbox by selecting the desired number and size of gears such that the gear ratio of the gearbox is between about 40:1 and about 150:1, in view of Cecchi, as a matter of routine optimization in order to more precisely deliver the amount of fluid called for during a procedure and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 41, 42, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Royo et al. (U.S. Patent Application Publication No. 20020045854; hereinafter “Royo”) in view of Lee.
Regarding claim 41, Royo discloses a method (para. [0017]) comprising:
advancing an expandable member (17) of a blood flow control device (Fig. 1) to a target location in a blood vessel of a patient (para. [0028]), wherein the expandable member is fluidly coupled to a syringe pump (1; Fig. 1);
in response to determining that the expandable member is to be deflated, moving a component of the syringe pump in a first direction to deflate the expandable member (paras. [0020], [0029]); and
after moving the component in the first direction, automatically moving the component in a second opposite direction (e.g., as part of an automatic operative mode that repeats inflation after deflation of the balloon; paras. [0030],[0035]-[0038]).
The method of Royo disclose the invention substantially as claimed, except for moving the component in the first direction to compensate for backlash in the syringe pump.
However ,Royo discloses that precise control of the inflating and deflating the balloon is a design feature of the method (para. [0017]).
Lee, a reference in the syringe pump field of endeavor, teaches moving a component of a syringe pump in a first direction to compensate for backlash in a syringe pump (e.g., amount to account for initial motor movement; para. [0102]) in order to provide a syringe pump with improved precision in delivering a desired amount of fluid during use (para. [0102]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method include moving the component of the syringe pump in the first direction to compensate for backlash in the syringe pump, in view of Lee, in order to allow the syringe pump to more precisely deliver the desired amount of fluid to and from the pump as called for by a procedure.
Regarding claim 42, Royo discloses where moving the component of the syringe pump in the first direction deflates the expandable member (para. [0020]).
Regarding claim 47, Royo discloses wherein the syringe pump comprises a plunger (2), and wherein moving the component in the first direction causes fluid transfer (para. [0020]).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Royo in view of Lee, as applied to claim 41 above, and further in view of Smith.
Regarding claim 48, the modified method discloses the invention substantially as claimed, except for the syringe pump including a screw (8) and nut (9) moving the plunger (Fig. 1; para. [0061]) to precisely draw fluid into or discharge fluid from the syringe (para. [0020]) instead of a linear gear and a circular gear.
Smith, a reference in the syringe pump field of endeavor, teaches configuring a syringe pump to include a plunger (810; Figs. 8-10) including a linear gear (rack; para. [0098]), and a controller comprising a circular gear (820), wherein the circular gear is operably coupled to the linear gear (Fig. 10) to move the plunger to precisely draw fluid into or discharge fluid from the syringe; para. [0106]).
Thus, a person having ordinary skill in the art would recognize the syringe pump of Royo and the syringe pump of Smith to be equivalent structures for moving a plunger to draw fluid into or discharge fluid from a syringe.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe pump configuration including a linear gear and a circular gear, as taught by Smith, for the syringe pump of Royo, to achieve the predictable result of precise movement of fluid into and out of the syringe and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Additionally, the modified method teaches wherein moving the at least one component in the second direction re-engages the linear gear with the circular gear (e.g., during “wind up;” Lee para. [0101]) without materially moving the plunger (e.g., wind up movement of the circular gear to take-up a mechanical gap with the linear gear does not materially move the plunger because the gears would not be in contact during such wind up movement).
Response to Arguments
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive.
On pages 9-10of the Response, Applicant argues that Smith does not disclose “coupling the syringe pump to a blood flow control device,” as recited in claim 1. This argument is not persuasive.
Examiner notes that the term “blood flow control device” is interpreted as encompassing devices that direct influence over (i.e., control) blood flow. This interpretation is consistent with the Specification because the claims and specification do not provide additional limitations on what constitutes a blood flow control device. Paragraph [0062] of the Specification discloses balloon catheters as an example of a blood flow control device, but does not provide a specific definition of the term “blood flow control device.”
As explained in this Office Action, Smith meets the limitation of “coupling the syringe pump to a blood flow control device” by disclosing coupling syringe pump (700) to an angiography catheter (740; para. [0101]). Angiography catheter (740) constitutes a “blood flow control device” as claimed because it is capable of directing influence over blood flow in a blood vessel by discharging fluid at a rate, pressure, or speed that would alter normal blood flow within the blood vessel (paras. [0106]-[0107]).
Applicant’s argument that Lee individually does not disclose coupling a syringe pump to a blood flow control device is not persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As presented in this Office Action, Smith meets the limitation of “coupling the syringe pump to a blood flow control device,” in the proposed combination of Smith and Lee.
On page 10 of the Response, Applicant argues that Lee does not disclose a component of a “syringe pump that moves a biasing movement amount in a second direction opposite a first direction to re-engage a first gear and the second gear.” (Response pg. 10). This argument is not persuasive.
As noted above, one cannot show nonobviousness by attacking references individually when references are combined.
Here, Smith discloses moving gear (820) in first and second opposite directions to engage rack (810) to move fluid into and out of the syringe pump (paras. [0098]-[0100]; Figs. 10-12).
Lee teaches moving a gear (48) an amount to account for take-up of mechanical gaps between the gear and a rack (46; para. [0101]) for more precise movement of fluid from a syringe pump (para. [0102]).
Hence, Smith and Lee taken in combination would teach or suggest to a person having ordinary skill in the art moving gear (820) of Smith a biasing movement amount in a second direction opposite the first direction to re-engage gear (820) with rack (810), because Smith discloses movement of the first gear in first and second opposite directions to draw fluid in or push fluid out of pump and Lee teaches moving a gear to account for a gaps between the gear and a rack.
For the reasons above, Examiner maintains that the invention of claim 1 is not allowable over the proposed combination of Smith and Lee.
Applicant’s argument that Cecchi, as applied to claim 9, does not cure the deficiencies of Smith and Lee (Response pg. 11) is not persuasive. As explained above, the combination of Smith and Lee is not deficient in meeting the limitations of claim 1.
On pages 11-12 of the Response, Applicant argues that the proposed combination of Royo and Lee does not meet the limitation “in response to determining that the expandable member is to be deflated, moving a component of the syringe pump in a first direction to compensate for backlash in the syringe pump and to deflate the expandable member,” as recited in claim 41, because Lee does not teach moving a syringe pump to deflate a balloon (Response pp. 11-12). This argument is not persuasive.
As noted above, one cannot show nonobviousness by attacking references individually when references are combined.
Here, Royo discloses moving components of a syringe pump in forwards and backwards directions to inflate or deflate a balloon catheter (para. [0020]). Royo further discloses that precise control of inflating and deflating the balloon catheter is a design feature of its syringe pump (para. [0017]).
Lee teaches moving components of a syringe pump to compensate for backlash in the syringe pump (para. [0101]) for precise movement of fluid via the pump (para. [0102]).
Hence, as Royo discloses movement of the syringe pump component in a first direction to deflate the balloon catheter and Lee teaches moving a component of a syringe pump to compensate for backlash for precise fluid movement via the pump, the prior art in combination would teach or suggest to a person having ordinary skill in the art moving a component of the Royo syringe pump in a first direction to compensate for backlash in the syringe pump and to deflate the expandable member.
For the reasons above, Examiner maintains that the invention of claim 41 is not allowable over the proposed combination of Royo and Lee.
Applicant’s argument that Smith, as applied to claim 48, does not cure the defect in Royo and Lee (Response pg.12) is not persuasive. As explained above, the combination of Royo and Lee is not deficient in meeting the limitations of claim 41.
For all the reasons above, Examiner maintains that the claimed invention is not patentable over the applied prior art.
Conclusion
Applicant's amendment necessitated any 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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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