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 .
Claims 1 and 3-15 are the currently pending claims. Claim 15 has been withdrawn; claim 2 has been canceled; and claims 1 and 3-14 are hereby under examination.
Election/Restrictions
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Claim Objections
Claims 3-5, 8, 10, and 12-14 are objected to because of the following informalities:
In claim 3, line 1: “sampling tube” is inconsistent with “collection tube” recited in claim 1, and the terminology should be made consistent;
In claim 4, line 1: “sampling tube” is inconsistent with “collection tube” recited in claim 1, and the terminology should be made consistent;
In claim 5, lines 9-10: “the puncture zone” lacks antecedent basis because the “puncture zone” is not previously introduced, and should be amended to introduce the puncture zone (e.g., --a puncture zone of the patient’s limb-- );
In claim 8: the claim inconsistently uses “mobile part” (line 3) and “movable part” (lines 7 and 8) to refer to a portion of the frame, the terminology should be made consistent, additionally "said movable part" (line 7) lacks clear antecedent basis as the term is first introduced in line 7;
In claim 10, lines 3-4: “the sampling tube” lacks clear antecedent and is inconsistent with “collection tube” recited in claims 10, 9, and claim 1, and the terminology should be made consistent;
In claim 12, lines 3-4: “needle-holder” is inconsistent with “needle holder” used in claims 1, 3, 8, 11, and 13, and the terminology should be made consistent;
In claim 13, line 4: “orient the bevel said needle” is grammatically incorrect and should be amended to --orient the bevel of said needle-- or equivalent; and
In claim 14, lines 2-3: “said puncture zone” lacks antecedent basis because the “puncture zone” is not previously introduced, and should be amended to introduce the puncture zone (e.g., --a puncture zone of the patient’s limb--) before reciting “said puncture zone”.
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 limitations are specified below for claims 1, 8-9, and 11-14.
Claim 1 recites “means for removably fixing the frame to said mechatronic assembly” in lines 6-7. The phrase “means for” coupled with purely functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification references “means for removably fixing the frame to the mechatronic assembly,” but does not provide further substantive description or structural detail for performing the removably fixing function beyond stating that such means “may be of any type” (Instant Application, [0089]). (see also the 112(b) section below).
Claim 1 recites “linear displacement means of said needle holder” in line 13. The term “means” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states: “The puncture head also comprises linear displacement means 16 of the needle holder 12 which are configured, once the needle holder 12 is equipped with a sampling needle 13, to enable the head to be armed in order to insert this needle into the limb of a patient to be punctured" (Instant Application, [0096]). The specification further states: “These linear displacement means of the needle holder are preferably formed by the robotic arm which carries the puncture head when the needle is inserted into the limb of the patient ...” (Instant Application, [0097]). The specification also describes an embodiment where “the movable portion being configured to be able to be moved, on command from a control unit and associated actuators ... in order to ensure the insertion/removal of the needle ... the movable portion thus forming the linear displacement means of the needle holder" (Instant Application, [0101]). The Examiner interprets “linear displacement means of said needle holder” as any mechanism (including motion provided by the robotic arm and/or actuators moving a movable portion relative to a fixed portion) that translates the needle holder to place the needle in a pre-insertion/armed position and/or to effect insertion and removal of the needle.
Claim 8 recites “a return means extending between the fixed part of said frame and said movable part of said frame” in line 4. The term “means” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states: “This electromechanical triggering system is illustrated schematically in FIG. 2. It comprises in particular an electromagnet 21 and a return spring 22 which is configured to ensure the return of the needle holder along slides 24 when the electromagnet 21 is no longer supplied with current” (Instant Application, [0098]). The specification further states: “During normal operation, a magnetic suction cup which forms the electromagnet is supplied with current so that the return spring 22 is held in a stretched state… the magnetic suction cup releases the movable portion of the head which is then displaced by the force of the spring 22 along the slides as far as a damping stop” (Instant Application, [0099]). The Examiner interprets “return means” as a biasing member (e.g., a spring) or equivalent structure that, upon de-energization of an electromagnet or equivalent structure, urges the movable portion of the frame toward the fixed portion to retract the needle.
Claim 9 recites “means for determining the filling level of the collection tube” in line 1. The phrase “means for” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states: “These means for determining the filling level may, for example, be formed by optical means for detecting the presence of blood in the filling tube… These means may also be formed by means for weighing the tube… These means may also be formed by means for calculating the filling time… Of course, other means may be used to determine the filling level of the collection tube” (Instant Application, [0060]). The specification further states: “This variant also enables the filling of the tubes to be detected and therefore enables control of the change of a filled tube for an empty tube to be filled as soon as the filling level reaches a predetermined level” (Instant Application, [0061]). The Examiner interprets “means for determining the filling level of the collection tube” as any sensor arrangement and/or computational technique that determines a quantity of blood in the collection tube, including optical blood detection, tube weighing, fill-time estimation using puncture time and flow-rate information, or equivalent techniques.
Claim 11 recites “means for detecting the entry of said needle mounted on said needle holder into a vein” in lines 2-3. The phrase “means for” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states that the head may comprise means for detecting the entry of the needle into a vein, but does not further describe the structure, sensing modality, or operational mechanism by which venous entry is detected, nor does it clearly link specific disclosed components to performing this function (Instant Application, [0065]). ((see also the 112(b) section below).
Claim 12 recites “means for fixing by screwing, clipping or magnetization of said puncture needle on said needle-holder” in lines 2-3. The phrase “means for” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification describes example structure for fixing the needle by screwing and/or clipping, but merely lists “magnetization” as an alternative without providing corresponding magnetic structure or explaining how magnetization performs the fixing function (Instant Application, [0069]; [0092]). (see also the 112(b) section below).
Claim 13 recites “a system for disengaging the rotation of said needle” in line 1. The phrase “system for” is a generic nonce term that fails to connote definite structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states: “According to one embodiment of the invention, the needle holder 12 also comprises means for disengaging the needle 13 which enable the needle 13 to be pivoted about the main axis thereof in order to enable the bevel of the needle to be orientated away from the skin of the patient to be punctured” (Instant Application, [0093]). The specification further states: “This disengagement is, for example, carried out by means of a thread of the needle holder which is pivotably mounted about the axis of the needle and which is held pressed against a retention plate by a spring… configured to generate a controlled friction” (Instant Application, [0094]). The Examiner interprets “a system for disengaging the rotation of said needle” as a mechanism that permits and/or controls rotation of the needle about its longitudinal axis relative to the needle holder to orient a bevel to a desired angular position, including a pivotable threaded member biased against a retention plate by a spring to provide controlled friction, or equivalent mechanisms.
Claim 14 recites “means for the automatic disinfection of said puncture zone” in line 1. The phrase “means for” coupled with functional language does not recite sufficient structure and is interpreted to invoke 35 U.S.C. § 112(f). The specification states: “Advantageously and according to the invention, the head further comprises means for automatically disinfecting the puncture zone” (Instant Application, [0073]). The specification further states: “These automatic disinfection means comprise, for example, a spray which is fitted to the head, a system for placing a cotton pad soaked with disinfectant products or any equivalent means” (Instant Application, [0074]). The Examiner interprets “means for the automatic disinfection of said puncture zone” as any mechanism that automatically applies a disinfectant to the puncture zone, including a disinfectant spray, a placement mechanism for a disinfectant-soaked pad, or equivalent disinfection applicators.
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 1 and 3-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1 recites “means for removably fixing the frame to said mechatronic assembly” in lines 6-7. When construed under 35 U.S.C. § 112(f), the specification fails to clearly identify corresponding structure for performing the recited removably fixing function, stating only that “These fixing means 11 may be of any type and are dependent on the robotic arm on which the puncture head is mounted.” (Instant Application, [0089]). The Examiner interprets “means for removably fixing the frame to said mechatronic assembly” as any detachable mechanical coupling between the frame and the mechatronic assembly that permits mounting and removal without destructive disassembly. (112(f)-related).
Claims 3-4 are rejected by virtue of their interpreted dependence from claim 1 (see the below rejection under 35 U.S.C. 112(d)).
Claims 5-14 are rejected by virtue of their dependence from claim 1.
Claim 1 recites “an electromechanical device for disarming the head and emergency removal of said needle … configured to allow … an exclusively mechanical removal” in lines 20-22. The limitation is internally inconsistent because an “electromechanical device” is incompatible with “exclusively mechanical removal” without further clarification. The Examiner interprets the “electromechanical device for disarming the head and emergency removal” as any powered release mechanism that, upon a command or loss of power, causes withdrawal of the needle from the patient’s limb by a mechanical biasing force or mechanical linkage.
Claim 5 recites “motorized dressing holder comprising a suction cup plate for holding a dressing carried by a hollow shaft pivoting relative to said frame” in lines 2-4. The claim is indefinite because it is ambiguous whether (i) the suction cup plate is carried by the hollow shaft, (ii) the dressing is carried by the hollow shaft, or (iii) both the suction cup plate and the dressing are carried by the hollow shaft. This ambiguity renders the structural relationship between the suction cup plate, the hollow shaft, and the dressing unclear and the scope of the claim subject to multiple reasonable interpretations. Accordingly, the claim is indefinite under 35 U.S.C. § 112(b). The Examiner interprets the “motorized dressing holder” as any powered mechanism that positions a dressing via suction and places the dressing onto the patient’s skin at or near a puncture site.
Claims 6 and 7 are rejected by virtue of their dependence from claim 5.
Claim 10 recites that the filling-level determining means are configured to “trigger an automatic change of the sampling tube” in lines 3-4. The claim fails to define what constitutes “triggering” and further introduces inconsistent terminology (“sampling tube” versus “collection tube”), rendering the scope indefinite under 35 U.S.C. § 112(b). The Examiner interprets “trigger an automatic change” as generating any control signal and/or command that initiates replacement of a currently engaged tube with another tube.
Claim 11 recites “means for detecting the entry of said needle mounted on said needle holder into a vein” in lines 2-3. When construed under 35 U.S.C. § 112(f), the specification does not clearly link or associate corresponding structure with the recited detecting function, stating only that such means are provided (Instant Application, [0065]). Accordingly, the claim is indefinite under 35 U.S.C. § 112(b). The Examiner interprets “means for detecting the entry of said needle … into a vein” as any sensor arrangement that detects venous entry based on a sensed condition associated with blood vessel access. (112(f)-related).
Claim 12 recites “means for fixing by screwing, clipping or magnetization of said puncture needle” in lines 2-3. When construed under 35 U.S.C. § 112(f), the specification fails to disclose corresponding structure for the “magnetization” alternative, beyond merely listing it as an option (Instant Application, [0069]; [0092]). Accordingly, the claim is indefinite under 35 U.S.C. § 112(b) at least as to the magnetization alternative. The Examiner interprets the “magnetization” alternative as any magnetic coupling arrangement that retains the puncture needle on the needle holder. (112(f)-related).
Claim 13 is rejected by virtue of its dependence from claim 12.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 depends from claim 2, which is canceled, and therefore fails to particularly point out and distinctly claim the subject matter which the inventor regards as the invention because the dependency does not further limit a claim in dependent form. Claim 3 should be amended to depend from a valid previous claim, canceled, or rewritten in independent form. The Examiner is interpreting that claim 3 (and through dependency, claim 4) depends from claim 1.
Claim 4 is rejected by virtue of its dependence from claim 3.
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.
Claims 1 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei.
Regarding claim 1, Harris teaches that a blood puncture head intended to equip a mechatronic assembly such as a robotic arm, of an automatic or semi-automatic blood sampling machine configured to allow movement of said head above a limb of a patient to be punctured (Harris, ¶[0039]: “an autonomous intravenous insertion system 8 of the present disclosure, having an insertion module 215 attached to a robot arm 1”, showing a blood draw capable insertion module attached to a robotic arm for positioning above a patient limb; ¶[0040]: “medical device holding tools of the present disclosure include the needle tool 3 for handling blood drawing equipment”, showing that the robotic arm system is configured for blood sampling via a needle tool) comprises: a frame equipped with means for removably fixing the frame to said mechatronic assembly (Harris, ¶[0067]: “The female tool changer 10 may be attached to the top of the needle tool 3 to autonomously connect the needle tools to the robot arm 1”, showing a tool changer interface that removably fixes the needle tool to the robotic arm); and a needle holder carried by said frame and adapted to receive a needle comprising a beveled portion intended to pierce the skin of the patient's limb to be punctured and a rear portion intended to allow the flow of collected blood to a collection tube (Harris, ¶[0067]: “The butterfly needle 41 may be gripped by a needle gripper assembly 200 comprising gripper fingers 42, a butterfly needle gripper body 46, a pneumatic piston 44, and butterfly needle gripper linkages 53”, showing a needle holder (needle gripper assembly 200 with gripper fingers 42) that is part of, and carried by, the needle tool 3 so as to receive and hold the needle; ¶[0067]: “FIG. 11 shows a perspective view of an embodiment of the needle tool 3”, showing that the needle holder is carried by the structure of the needle tool 3, which corresponds to the claimed “frame”; Abstract and FIG. 11, the depicted butterfly needle includes a beveled distal needle tip for piercing the skin of the arm, showing the claimed “beveled portion”; ¶[0072]: “pressed onto the piercing needle 72, allowing blood to flow from the butterfly needle 41 through a tube to the piercing needle 72, and into the blood drawing tube 78”, showing that the needle (as mounted/used in Harris) includes a rear interface portion that enables blood flow into a collection tube (blood drawing tube 78), see also figure 18); wherein said blood puncture head further comprises: linear displacement means of said needle holder configured to allow, once equipped with a needle, to arm the puncture head with a view to inserting, on command from said mechatronic assembly, this needle in said limb of said patient in order to be able to take a blood sample (Harris, ¶[0068]: “To insert the butterfly needle 41, the stepper motor 43 pushes the needle gripper assembly 200 forward, thus inserting the butterfly needle 41 into a target vein”, showing linear displacement of a needle holder for inserting the needle into the patient; ¶[0070]: “The butterfly needle 41 has been inserted into the patient’s arm 7 by turning the lead screw 52 with the stepper motor 43, driving the needle gripper assembly 200 forward along guide rails 45”, showing a linear actuator system that arms and advances the needle holder for insertion; see FIG. 2b and 13-14); a device for fluidically connecting said rear portion of said needle mounted on said needle holder with a collection tube adapted to collect the blood taken from said patient's limb (Harris, ¶[0072]: “the autonomous intravenous insertion system 8 has an automatic dispenser unit 74 that engages, disengages, and exchanges blood drawing tubes 78 with the inserted butterfly needle 41”, showing a device that connects a blood drawing tube to the inserted butterfly needle; ¶[0072]: “pressed onto the piercing needle 72, allowing blood to flow from the butterfly needle 41 through a tube to the piercing needle 72, and into the blood drawing tube 78”, showing fluidic connection enabling blood flow into a collection tube; see also FIG. 18); wherein said fluidically connecting device is motorized and further comprises a device for loading and distributing blood collection tubes comprising at least one housing for receiving a collection tube and at least one securing actuator of this collection tube to the rear of a needle mounted on said needle holder, said securing actuator being configured to move said collection tube from the receiving housing to the rear portion of said needle and vice versa (Harris, FIG. 16-19; ¶[0072]: “the autonomous intravenous insertion system 8 has an automatic dispenser unit 74 that engages, disengages, and exchanges blood drawing tubes 78 with the inserted butterfly needle 41”, showing a motorized system for loading, distributing, and exchanging collection tubes relative to the needle; ¶[0072]: “the manipulator 210 includes a carriage 70 sliding along a guide rail 76, propelled by the rotation of a lead screw 77”, showing a motorized actuator that moves a tube holder between positions; ¶[0074]: “the carriage 70 is driven by the rotation of the lead screw 77 to push the blood drawing tube 78 onto the piercing needle 72”, showing an actuator moving the tube to a rear needle interface for connection).
Also regarding claim 1, Harris does not fully teach that an electromechanical device for disarming the head and emergency removal of said needle from said patient's limb is configured to allow, on command, an exclusively mechanical removal of said needle from said patient's limb. Rather, Harris teaches an emergency stop feature for a computer-controlled robot arm that can immediately cease motion and retreat to a home position, which places the puncture head into a safe, non-inserting state and thereby disarms the puncture head by terminating active insertion forces and withdrawing the head away from the patient’s limb (Harris, ¶[0041]: “An emergency stop Switch 13 may be present in case of system malfunction, allowing immediate cessation of the motion of the robot arm 1”; ¶[0041]: “If the robot arm 1 is stopped in either of these ways, it may retreat to its original home position”; see also ¶[0089]). Harris also has an emergency abort feature and stop feature that “can stop the procedure at any time. In addition, the system 8 may include an option for the user to extract the medical device tool 212 at any time during the procedure” (Harris, ¶[0109]; ¶[0113]). However, Harris does not explicitly teach that the emergency removal of the needle from the patient’s limb is accomplished by an exclusively mechanical withdrawal force upon the emergency command (such as a power-loss condition).
Wei teaches a needle retraction where de-energizing an electromechanical drive causes a needle to be withdrawn by a purely mechanical spring bias, stating that “Once the solenoid drive 110 is de-energized, the solenoid push rod 1101 retracts and the needle frame spring 100 extends. The extension of the needle frame spring 100 moves the injection needle 90 from deployed state back to the retracted state, and the needle pointed end 91 is withdrawn from injection site”(Wei, ¶[0031]). This provides a mechanical withdrawal action of the needle when the electromechanical drive is de-energized in response to an emergency stop command, wherein the same mechanical withdrawal occurs if power to the drive is interrupted (such as in a power-loss emergency).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Harris in view of Wei to provide an electromechanical emergency command that de-energizes a needle drive or release such that a mechanical biasing member withdraws the needle from the patient’s limb. This would have been obvious and possible because Harris already includes computer control and an emergency stop behavior for halting and retreating the robotic arm, and Wei teaches a straightforward spring-biased retraction that occurs when an electromechanical drive is de-energized, which could be implemented in Harris’s needle tool as a spring-biased withdrawal linkage or needle-holder/gripper bias that retracts upon emergency stop or power interruption. The benefit of the combination is improved safety and reliability during malfunction or emergency stop by ensuring the needle is removed from the patient through a mechanical biasing force even when powered actuation is halted.
Regarding claim 11, the modified Harris teaches that the puncture head has means for detecting the entry of said needle mounted on said needle holder into a vein of the patient to be punctured (Harris, FIG. 25-27; ¶[0110]: “a force sensor is provided to relay data about the penetration of the butterfly needle 41 or catheter 22 through the wall of the W1”, teaches a force sensor that relays data about penetration through the vein wall, which is conceptually and functionally equivalent to detecting entry of the needle into the vein; ¶[0109]: “the motion control decision engine 111 continues to monitor sensory information to ensure that it remains safe to insert the medical device tool 212 into the patient's arm 7”, shows continued monitoring of sensory information during insertion, consistent with using the force-sensor penetration data to detect the event during puncture, where the control decision engine 111 also uses video and ultra sound input of the vein and needle for decision control (see also ¶[0111])).
Regarding claim 12, the modified Harris teaches wherein said needle-holder comprises means for fixing by screwing, clipping or magnetization of said puncture needle on said needle-holder (Harris, ¶[0067]: “The butterfly needle 41 may be gripped by a needle gripper assembly 200 comprising gripper fingers 42, a butterfly needle gripper body 46, a pneumatic piston 44, and butterfly needle gripper linkages 53”, shows a needle holder with gripper fingers that grip the needle, which is conceptually and functionally equivalent to clipping the puncture needle on the needle holder; ¶[0071]: “To grip the butterfly needle 41, air pressure may be applied behind the pneumatic piston 44 inside the gripper body 46, causing the butterfly needle gripper linkages 53 to spread the backs of the butterfly needle gripper fingers 42, closing them on the butterfly needle 41”, further shows the gripper fingers close on the needle to fix the needle on the needle holder, which is conceptually and functionally equivalent to clipping).
Claims 3 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Balter (Balter, Max Loeb. "Design and Characterization of a Fully Automated Blood Sampling System", Ph.D. Dissertation, Rutgers, The State University of New Jersey, Graduate Program in Biomedical Engineering, 2017), hereto referred as Balter.
The modified Harris teaches claim 1 as described above.
Regarding claim 3, the modified Harris teaches that the tubes are secured at the rear of said needle, under the effect of said securing actuator formed by a linear actuator for moving the tube housed in the receiving housing aligned with said needle (Harris, FIG. 16-19; ¶[0072]: “the manipulator 210 includes a carriage 70 sliding along a guide rail 76, propelled by the rotation of a lead screw 77”, showing a linear actuator arrangement for moving a tube holder relative to the needle; ¶[0074]: “the carriage 70 is driven by the rotation of the lead screw 77 to push the blood drawing tube 78 onto the piercing needle 72”, showing the securing actuator formed by a linear actuator that moves the tube from a receiving position to the rear needle interface).
Also regarding claim 3, the modified Harris does not fully teach that said device for loading and distributing sampling tubes comprises a barrel comprising a plurality of housings for receiving tubes distributed around an axis of rotation of said barrel, said axis of rotation extending parallel to the axis of said needle, once the needle is mounted on said needle holder, and separated from this axis by a distance equal to the distance which separates said axis of rotation of said barrel from each of said housings for receiving said tubes, so that each tube can be aligned with said needle, by rotation of said barrel. Rather, the modified Harris teaches a motorized tube handling subsystem that engages, disengages, and exchanges blood drawing tubes with an inserted needle, and teaches using a linear actuator arrangement to drive a blood drawing tube onto a rear needle interface, stating that “the autonomous intravenous insertion system 8 has an automatic dispenser unit 74 that engages, disengages, and exchanges blood drawing tubes 78 with the inserted butterfly needle 41” (Harris, ¶[0072]:) and that “the carriage 70 is driven by the rotation of the lead screw 77 to push the blood drawing tube 78 onto the piercing needle 72” (Harris, ¶[0074]:). However, Harris is unclear as to the particular tube storage and selection arrangement, and does not clearly teach a barrel or carousel comprising a plurality of tube housings distributed around a barrel axis of rotation that indexes different tubes into alignment with the needle by rotating the barrel.
Balter teaches a clear carousel design choice for tube arrangement management that indexes tubes by rotation into an engagement position, stating that “the sample handling module consisted of two units—a blood collection carousel that housed the Vacutainer tubes” (Balter, FIG. 3.2-3.3, 3.6-3.8; p. 120, Sec. 3.1.2) and that the carousel “consisted of a holder tray for eight 5 ml Vacutainer blood vials seated on a rotary stepper motor” (Balter, p. 120-121, Sec. 3.1.2.1). Balter further teaches tube-by-tube indexing such that rotation aligns a single tube position for engagement, stating that “After the vial is full, the linear stage rises, and the carousel rotates to the next vial position” (Balter, p. 120-121, Sec. 3.1.2.1). In context, Balter’s carousel is a barrel-like tube loader and distributor with multiple tube housings distributed around a rotation axis such that, by rotating the carousel, a selected single tube housing is aligned for engagement with a needle during automated sampling. Further, Balter’s Figures 3.2–3.3 and 3.6–3.8 depict the carousel arranged such that the axis of rotation of the carousel extends parallel to the axis of the needle, with each tube position located at a fixed radial distance from the carousel axis, such that rotation of the carousel brings a single tube into axial alignment with the needle for engagement.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Balter to provide, as a tube arrangement management design choice, a barrel-like rotating tube carousel comprising a plurality of tube housings distributed around an axis of rotation, such that rotation of the carousel aligns a single tube housing axis with the needle axis for subsequent engagement and exchange, while retaining Harris’s actuator arrangement for securing the aligned tube at the rear of the needle. This would have been obvious and possible because Harris already teaches automated engagement, disengagement, and exchange of blood drawing tubes with a needle and teaches a lead screw driven carriage for pushing a tube onto a rear needle interface, and Balter teaches a well-understood rotary carousel architecture for storing multiple Vacutainer tubes and indexing them by rotation to successive tube positions, which could be implemented as the tube storage and selection portion of Harris’s dispenser unit. The benefit of the combination is improved automated multi-tube sampling by providing deterministic, indexed tube presentation at a known geometric relationship to the needle, reducing mechanical complexity during tube exchange, improving alignment repeatability and reliability across successive samples, and minimizing operator intervention and downtime during multi-tube collection.
Regarding claim 8, the modified Harris teaches that said frame comprises a fixed part fitted with means for removable fixing to said mechatronic assembly and a mobile part carrying at least said needle holder and said fluidic connection (Harris, ¶[0039]: "a tool changer system having a male tool changer 9 and a female tool changer 10 is used for connecting medical device holding tools, such as the needle tool 3 ... , to the robot arm 1", showing the claimed removable fixing between the robotic arm and the needle tool/frame; ¶[0067]: "The female tool changer 10 may be attached to the top of the needle tool 3 to autonomously connect the needle tools to the robot arm 1", showing the claimed fixed part of the frame fitted with means for removable fixing; ¶[0071]: "The needle gripper assembly 200 is moveable by the stepper motor 43 along the axis of the butterfly needle 41", and "As the lead screw 52 turns, the gripper body 46 slides along the guide rails 45, moving the gripper fingers 42 and the butterfly needle 41 with it", showing a mobile part that carries the needle holder (gripper assembly/fingers) and moves relative to the remainder of the needle tool; ¶[0072]: "the autonomous intravenous insertion system 8 has an automatic dispenser unit 74 that engages, disengages, and exchanges blood drawing tubes 78 with the inserted butterfly needle 41" and "the manipulator 210 includes a carriage 70 sliding along a guide rail 76, propelled by the rotation of a lead screw 77", showing a movable tube-connection subassembly (carriage/collet chuck/manipulator) that carries the fluidic connection components and moves relative to the remainder of the tube handling structure).
Also regarding claim 8, the modified Harris does not fully teach that said electromechanical device for disarming and emergency withdrawal comprises an electromagnet and a return means extending between the fixed part of said frame and said movable part of said frame, and configured to ensure the return of the movable part of said frame to the fixed part of said frame when said electromagnet is no longer supplied with current. Rather, the modified Harris (as modified in claim 1 above) teaches an autonomous blood draw system having a robot arm that positions a blood puncture head above a patient limb, and further teaches an emergency stop behavior that ceases motion and retreats to a safe position, and further provides emergency needle withdrawal behavior. However, the modified Harris does not expressly teach using an electromagnet as part of the puncture head/end-effector to selectively hold and release a needle component as part of the automated blood draw mechanism.
Balter teaches an autonomous venipuncture workflow in which "The robot grabs the needle using an electromagnet (EM) embedded in the end-effector" (Balter, p. 31, Sec. 2.2.1), and further teaches an EM-based needle grip-and-release mechanism where "The first design consisted of an EM embedded in the end-effector of the manipulator arm" and "When the EM is turned on, the end-effector securely grabs the needle..." and that the needle can be disposed/released "by turning off the EM" (Balter, p. 54, Sec. 2.2.4.1, see also FIG. 2.6, 2.11, and 2.20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Harris to incorporate Balter’s electromagnet-based needle gripping/release mechanism as part of the puncture head/end-effector, thereby satisfying the electromagnet limitation of claim 8. A person of ordinary skill in the art would have found it obvious to do so because Balter evidences a known, simple, and controllable approach for autonomous handling of a needle by selectively energizing/de-energizing an electromagnet embedded in the end-effector, and the modified Harris already provides a robot arm, end-effector tools, and computer control suitable for integrating an alternative needle holding/release subassembly. The benefit of the combination would have been improved autonomous needle handling and safety (e.g., controlled release/disposal and/or controlled disengagement in emergency handling) while maintaining the overall automated blood draw functionality of the modified Harris system.
Regarding claim 9, the modified Harris does not fully teach that it further comprises means for determining the filling level of the collection tube in fluidic connection with said sampling needle. Rather, the modified Harris teaches an autonomous intravenous insertion system as shown in claim 1 above, including automated engagement/disengagement and exchange of blood drawing tubes with an inserted needle, but the modified Harris does not expressly teach determining a filling level of the collection tube in fluidic connection with the sampling needle.
Balter teaches automated blood collection that includes determining a collected volume/filling level and using that determination to advance/rotate to a next tube, stating that “Once 4 ml of blood is collected (as confirmed by a compact 780 nm laser diode and photodetector), the zc1-stage rises and the carousel rotates to the next vial” (Balter, p. 125, Sec. 3.1.3.1). Balter further teaches a collection carousel process in which “After the vial is full, the linear stage rises, and the carousel rotates to the next vial position” (Balter, p. 120-121, Sec. 3.1.2.1:), showing system behavior driven by a determination that the vial has reached a filled condition.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Balter to provide means for determining the filling level of the collection tube in fluidic connection with the sampling needle. This would have been obvious and possible because Harris already includes automated engagement and exchange of collection tubes in a controlled robotic system, and Balter teaches using a compact optical sensing arrangement (laser diode and photodetector) to confirm a collected volume/fill level and to trigger tube-advancement behavior. The benefit of the combination would have been improved automation reliability and sample control by enabling the system to determine when adequate blood volume has been collected in a tube and to support automated tube-handling decisions based on a determined filling level.
Regarding claim 10, the modified Harris does not fully teach that said means for determining the filling level of the collection tube are configured to be able to trigger an automatic change of the sampling tube. Rather, the modified Harris teaches an autonomous intravenous insertion system including automated engagement/disengagement and exchange of blood drawing tubes with an inserted needle, including fill detection as shown above in claim 9. However, the modified Harris does not expressly teach that a fill-level determination is used as the trigger that causes an automatic change of the sampling tube.
Balter teaches that a determined collected volume/fill level triggers automatic advancement to a next tube, stating that “Once 4 ml of blood is collected (as confirmed by a compact 780 nm laser diode and photodetector), the zc1-stage rises and the carousel rotates to the next vial” (Balter Dissertation, p. 125, Sec. 3.1.3.1). Balter further teaches a carousel process where “After the vial is full, the linear stage rises, and the carousel rotates to the next vial position” (Balter Dissertation, p. 120-121, Sec. 3.1.2.1), showing an automatic change to a next sampling tube triggered by a filled condition.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Balter such that the means for determining the filling level of the collection tube are configured to be able to trigger an automatic change of the sampling tube. This would have been obvious and possible because Harris already includes a tube handling mechanism that exchanges tubes, and Balter teaches a straightforward control approach where a sensor-confirmed collected volume/fill level causes the system to advance to the next vial. The benefit of the combination would have been improved automation by enabling automatic tube change decisions based on a determined fill level, thereby reducing clinician intervention and improving consistency of collected sample volumes.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Balter (Balter, Max Loeb. "Design and Characterization of a Fully Automated Blood Sampling System", Ph.D. Dissertation, Rutgers, The State University of New Jersey, Graduate Program in Biomedical Engineering, 2017), hereto referred as Balter, and further in view of Scientific Industries (Scientific Industries Product Brochure, 2018-2019, Accessed via web on 1-8-2026, www.labrepco.com/wp-content/uploads/2019/02/Scientific-Industries-Product-Brochure-2018-2019.pdf?srsltid=AfmBOooR_6t60YNzJGHDTMw0m1RlR5mNtFwZyLHKjzJzxs8i9UwzCe0h), hereto referred as Scientific Industries.
The modified Harris teaches claim 1 and claim 3 as described above.
Regarding claim 4, the modified Harris does not fully teach that said housings for receiving the sampling tubes formed at the periphery of said loading and dispensing barrel comprise loops for clipping said tubes. Rather, the modified Harris teaches an automatic dispenser unit that engages, disengages, and exchanges blood drawing tubes with an inserted needle, as shown above in claim 3. However, the modified Harris does not clearly teach that the tube housings formed at the periphery of the barrel or carousel comprise loops for clipping the tubes into place.
Scientific Industries teaches tube holders that retain tubes via clip structures, including “Plastic Clip Microtube Holder” among a myriad of tube holding options via clips (Scientific Industries, p. 3, 21). In context, Scientific Industries’ clip holders and clip plates provide tube receiving positions that mechanically clip or loop around a tube to retain it, which corresponds to the claimed loops for clipping tubes formed at the periphery of a tube loading and dispensing barrel, much like the depiction in the Instant Application of parts 27.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Scientific Industries to have provided the tube housings at the periphery of the tube loading and dispensing barrel or carousel with loops or clip structures for clipping and retaining the tubes. This would have been obvious and possible because the modified Harris already teaches presenting multiple tubes for automated engagement and exchange, and Scientific Industries teaches a known tube retention approach using clip structures that can be implemented as the tube-retaining features of each tube housing on the barrel or carousel without changing the overall tube indexing or tube exchange operation. The benefit of the combination is improved tube retention and handling reliability during rotation and movement of the tube loader by securely holding each tube in its housing, reducing the risk of tube slippage or misalignment, and supporting repeatable tube exchange during automated sampling.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Soto (US 8888714 B1), hereto referred as Soto, and further in view of Whitby (US 20020088553 A1), hereto referred as Whitby.
The modified Harris teaches claim 1 as described above.
Regarding claim 5, the modified Harris does not fully teach that it further comprises a motorized dressing holder comprising a suction cup plate for holding a dressing carried by a hollow shaft pivoting relative to said frame between a position for loading a dressing in which said suction cup can come into contact with a dressing dispenser outside said head in order to be able to suck up a dressing by placing said hollow shaft under vacuum, in a position for placing the dressing, in which said dressing carried by said suction cup comes into pressed contact with the skin of said patient's limb at the level of the puncture zone, during withdrawal of said needle from said patient's limb in order to be able to affix said dressing on said patient's limb by venting said hollow shaft, thereby releasing said dressing. Rather, the modified Harris teaches an autonomous blood sampling arrangement including a needle insertion tool and automated blood collection tube handling, as set forth in claim 1 above. However, the modified Harris does not teach a motorized dressing holder that holds and applies a dressing via a suction cup plate on a pivoting hollow shaft that is placed under vacuum to pick up the dressing and vented to release the dressing onto the puncture site.
Soto teaches automated post puncture dressing placement tied to needle removal, including removing the needle and lowering gauze onto the puncture site and placing pressure to stop bleeding, and then applying tape to secure the gauze as a bandage (Soto, FIG. 1; Col. 7, ll. 29-48: “may include a gauze and gauze storage chamber 6, within the housing, such that the system may remove the one or more needles 4 and/or the intravenous catheters 22 from the user's vein, lower the gauze 6 onto the target area, and place pressure on the target area to stop any bleeding from the user's punctured vein”; Col. 7-8, ll. 49-20: “the housing includes a paper tape 23, Such that after the respective time of pressure being placed on the users arm, using the computer system, the system may place the paper tape 23 onto the gauze 6 on the users arm, in order to secure a bandage on the user's target area”). In context, Soto establishes that automated wound care is part of an automated blood draw workflow and expressly links dressing placement to the needle removal sequence (“remove… needles… lower the gauze… onto the target area”), which corresponds to applying a dressing during withdrawal/removal rather than as a separate manual step. However, Soto does not provide the specific mechanical implementation for how the gauze is grasped, transported from a source, and released onto the skin.
Whitby teaches a vacuum-actuated wand having a vacuum cup at a distal end for picking up a thin, flexible sheet-like item by suction when vacuum is applied, and releasing the item when the vacuum is terminated (Whitby, ¶[0026]: “no vacuum is applied to the wand assembly”; “a vacuum is applied to the wand assembly … to attract and pick-up the label”; “Vacuum applied at opening 116 may be terminated”, and ¶[0028]: “A vacuum cup 222 … defines a label pick-up opening 224 at the end of the wand assembly 200” and “termination of the vacuum allows the Spring 232 to return the wand assembly 200”). Whitby FIG. 4 depicts the vacuum cup as having a substantially planar engagement surface configured to contact a flat sheet-like item, such that the vacuum cup functions as a suction cup plate for holding the item by vacuum during transport and placement. Whitby further teaches that the wand is a hollow/channeled structure that transmits vacuum from a proximal vacuum opening through internal passages to the distal vacuum cup opening (Whitby, FIG. 4-5; ¶[0028]: “vacuum opening 208, a vacuum passage 210”; “A passage 226 extends away from opening 224 …”; and “Alignable transfer ports … provide fluid communication between the vacuum opening 208 and label pick-up opening 224”). Whitby also teaches venting/pressure equalization to remove the suction holding force, because portions of the wand assembly are expressly in communication with ambient atmosphere (Whitby, ¶[0028]: “Chamber 218 is open to ambient atmosphere via a port 220”; ¶[0022]: “A passage 130 maintains the chamber 124 in communication with ambient atmosphere”), and Whitby explains that when vacuum is terminated “the pressure differential is removed” such that the wand returns (Whitby, ¶[0025]). A person of ordinary skill in the art would understand that “termination of the vacuum” implicitly requires ceasing suction such that the internal passages are no longer under vacuum (i.e., are vented/equalized to ambient) so the vacuum cup no longer exerts a holding force on the dressing and the dressing releases. Additionally, Whitby teaches the wand is pivoted and extended/retracted between a pick-up station and an applying station (Whitby, FIG. 1; ¶[0002]: “wands which are pivoted between label pick up stations and label applying Stations”; ¶[0026]"a vacuum is applied to the wand assembly 100 causing the wand assembly 100 to be placed in the extended position... may be terminated allowing the wand assembly to return to the non-extended position"), and Whitby supports that such motion can be automated and powered because it teaches coordinated control of wand movement and vacuum application via a controller and expressly contemplates electronic control or combined electro-mechanical control (Whitby, ¶[0027]: “Movement of the wand pivoting assembly and application of the vacuum can be controlled via a controller … The controller maybe an electronic controller … or a combination of the two”). Whitby FIG. 1 and FIG. 5 further show that the wand assembly extends outward from the body of the apparatus to reach both the pick-up station and the applying station, such that the vacuum cup is positioned outside the housing of the apparatus when retrieving and applying the item. Whitby is reasonably pertinent to the dressing-holder limitation because it addresses the same technical problem of automatically picking up, transporting, and releasing a thin, flexible sheet-like item using vacuum retention and controlled release on a movable member, which is directly applicable to automated handling and placement of a wound dressing in an autonomous blood draw system.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Soto and Whitby to have included a motorized dressing holder comprising a suction cup plate carried by a hollow shaft pivoting relative to the frame between a dressing loading position and a dressing placing position, wherein the hollow shaft is placed under vacuum to pick up a dressing and vented to release the dressing onto the puncture zone during withdrawal of the needle. This would have been obvious and possible because Soto teaches that an automated blood draw workflow includes removing the needle and lowering gauze onto the puncture site to apply pressure and secure a bandage, and Whitby teaches a known automated mechanism for picking up and releasing a thin flexible sheet-like item using a vacuum cup on a pivoting wand between a pick-up station and an applying station with internal vacuum passages transmitting suction to the distal end, such that the suction wand can be implemented as an additional end-effector function in the modified Harris system to retrieve a dressing from a dispenser outside the puncture head and place it onto the puncture zone as the needle is being withdrawn without changing the fundamental automated blood sampling operation. The benefit of the combination is improved automation and consistency of post puncture wound care by enabling reliable, hands free placement and controlled release of a dressing at the puncture site immediately upon needle withdrawal, reducing bleeding and reducing manual intervention by healthcare staff.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Soto (US 8888714 B1), hereto referred as Soto, and further in view of Whitby (US 20020088553 A1), hereto referred as Whitby, and further in view of Zheng et al. (CN 110934687 A), hereto referred as Zheng.
The modified Harris teaches claim 1 and claim 5 as described above.
Regarding claim 6, the modified Harris does not fully teach that said suction cup plate of the dressing holder comprises a recess allowing the passage of the needle during the fitting of the dressing. Rather, the modified Harris (as modified in claim 5) teaches an autonomous blood sampling arrangement including a needle insertion tool and automated blood collection tube handling, and further teaches automated dressing placement during withdrawal of the needle using a suction cup plate. However, the modified Harris does not teach a recess allowing the passage of the needle during the fitting of the dressing.
Zheng teaches a puncture-site dressing assembly configured to be placed at the puncture location while the puncture needle is still present, including a structure where “the base and the medical adhesive patch together form an installation hole” and the dressing material (medical cotton) is “located below the installation hole” (Zheng, ¶[0008]). Zheng further teaches a usage sequence where, “After intravenous puncture and before needle removal", the medical cotton is aligned with the puncture hole and the puncture needle is secured in a fixing hole (Zheng, ¶[0018]). In context, Zheng evidences that, during placement/affixing of a dressing at a puncture site with the needle still present (or during withdrawal), it was known to provide an opening/clearance region (installation hole) through a dressing support structure aligned to the puncture site, thereby accommodating the puncture needle and enabling proper dressing placement at the puncture zone without interference from the puncture needle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Zheng to have included a recess allowing the passage of the needle during the fitting of the dressing, because Zheng teaches a dressing assembly applied at a puncture site “before needle removal” and configured with an “installation hole” formed through the dressing support structure for dressing application, evidencing a known, compatible design for accommodating a puncture needle while placing/affixing a dressing at the puncture zone. This modification would have been obvious and possible because it is a predictable structural adaptation of the dressing-holding/applying mechanism already taught by Soto and Whitby in the modified Harris system, and would not change the principle of operation of the automated blood draw device. The benefit of the combination is improved robustness and safety of automated dressing placement by ensuring the dressing can be applied at the puncture zone while accommodating the needle during withdrawal, thereby reducing snagging/interference and improving consistent coverage of the puncture site.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Soto (US 8888714 B1), hereto referred as Soto, and further in view of Whitby (US 20020088553 A1), hereto referred as Whitby, and further in view of Zheng et al. (CN 110934687 A), hereto referred as Zheng, and further in view of Hellmer (US 4359314 A), hereto referred as Hellmer.
The modified Harris teaches claim 1 and claim 5 as described above.
Regarding claim 7, the modified Harris does not fully teach that said suction plate is pivotable with respect to the hollow shaft so as to be able to adapt to the curvature of the patient's limb at puncture, independent of the rotation and/or inclination of the puncture head. Rather, the modified Harris teaches a vacuum-actuated wand assembly that is pivoted as a unit between a pick-up station and a delivery/applying station and also describes a shaft that is pivoted through an angle (as modified in claim 5 above). However, it does not expressly teach that the suction cup plate itself is pivotable with respect to the hollow shaft (i.e., a relative pivot between the suction cup/plate and the elongated hollow shaft), as opposed to pivoting of the overall wand/shaft assembly.
Hellmer teaches a transfer head that includes a support plate (carrying suction cups) that is pivotally connected to an arm by a pivot pin (Hellmer, Col. 3, ll. 14-20: "The transfer head 42 includes a support plate 44... a mounting block 46 which is pivotally connected to an outer end portion of the arm 32 by means of a pivot pin 48."), and further teaches actuating pivoting of the transfer head around the end of the arm (Hellmer, Col. 3, ll. 33-42:"...effect the pivoting of the transfer head 42 around the end of the arm 32..."). In other words, Hellmer evidences the well-known design choice of providing a suction-cup support plate/transfer head that pivots relative to an elongated arm/shaft, rather than (or in addition to) pivoting only the entire arm/shaft as a unit.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Harris to further incorporate Hellmer’s pivotally-connected suction support plate arrangement, such that the suction cup plate is pivotable with respect to the hollow shaft. A person of ordinary skill in the art would have found it obvious to do so because providing a relative pivot between the suction cup plate and the hollow shaft would have enabled improved orientation control and placement compliance of the dressing during automated application (e.g., orienting the suction cup plate relative to the shaft while maintaining the shaft position), which is a predictable use of known pivoting transfer-head mechanics. The benefit of the combination would have been improved ability to align and apply the dressing reliably to the puncture site across varying approach angles and patient anatomies while leveraging the powered robotic positioning already present in the modified Harris system.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Glozman et al. (US 20200179066 A1), hereto referred as Glozman.
The modified Harris teaches claim 1 as described above.
Regarding claim 13, the modified Harris does not fully teach that wherein said needle holder further comprises a system for disengaging the rotation of said needle so as to allow selective rotation actuation of the needle about its longitudinal axis in order to be able to orient the bevel said needle away from the skin of the patient's limb to be punctured. The modified Harris teaches selecting and tracking a target insertion site, generating an insertion angle relative to the medical device tool, and inserting a needle beveled away from the skin (Harris, FIG. 2A-B, 11, 13-14: depicts needle bevel away from the skin; ¶[0131]: "the system 8 highlights potential insertion sites and, depending on the mode of operation, either selects a target site automatically or receives input from the user regarding the target insertion site in step 142" and "generates three-dimensional spatial coordinates and an angle relative to the medical device tool 212 in step 144" and "the system 8 inserts the butterfly needle 41, catheter 22, or other tool 80 in step 148"). However, the modified Harris does not expressly teach a needle holder system that disengages rotation to allow the needle to rotate on itself to orient the needle bevel away from the patient's skin.
Glozman teaches a robotic needle manipulator in which the needle gripper includes a needle rotation mechanism enabling the needle to be rotated about its axis (Glozman, ¶[0025]: “Additionally, a needle rotation mechanism may be incorporated, such that the needle can be rotated about its axis”, showing that Glozman expressly teaches imparting rotational motion to the needle about its longitudinal axis under robotic control). This needle rotation is used to effect the orientation of the needle's bevel (Glozman, ¶[0012], “In addition, rotation of the needle may be useful for use with beveled needle guidance systems, or, simply in order to keep the bevel at 90 degrees to the imaging plane”). Glozman further teaches a specific needle rotation mechanism includes a friction clutch arrangement (Glozman, FIGS. 5-6, ¶[0047]: “with the needle shaft passing through a friction clutch at its center, such that application of the clutch and rotation of the pulley wheel will rotate the needle”, showing a clutch-based mechanism that is selectively actuated to enable or disable needle rotation via a pulley).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Harris in view of Glozman to further provide a needle holder having a selectable rotation mechanism to enable or disable axial rotation to orient the bevel away from the skin of the patient’s limb to be punctured. Such a combination would have been possible by incorporating Glozman’s clutch-based needle rotation mechanism into Harris’s needle gripper assembly 200, such that the Harris needle gripper assembly 200 could selectively apply the friction clutch to couple rotational drive and rotate the needle about its longitudinal axis. The benefit of the combination would have been improved control and consistency of the needle’s bevel orientation during automated venipuncture, thereby enabling more reliable insertion outcomes while retaining Harris’s automated insertion workflow.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 20120190981 A1), hereto referred as Harris, and further in view of Wei (US 20180333532 A1), hereto referred as Wei, and further in view of Soto (US 8888714 B1), hereto referred as Soto.
The modified Harris teaches claim 1 as described above.
Regarding claim 14, the modified Harris does not fully teach that the puncture head also comprises means for the automatic disinfection of said puncture zone. The modified Harris teaches identifying and verifying a target insertion site over a patient’s limb, and controlling a robot arm and needle tool to move to that site and insert the needle into the patient’s vessel as shown above in claim 1. However, the modified Harris does not teach automatically disinfecting the puncture zone before insertion.
Soto teaches an autonomous system that disinfects a patient’s skin prior to needle insertion by applying an antiseptic (Soto, Col. 2-3, ll. 61-33: "the housing may include an antiseptic solution and/or one or more antiseptic pads, such that the computer system may secrete the antiseptic solution and/or one or more antiseptic pads onto the target area to wipe and clean the target area on the user's arm").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Harris in view of Soto to provide means for the automatic disinfection of the puncture zone prior to insertion. Such a combination would have been possible by configuring Harris’s automated robot arm and end-effector sequence to perform a dedicated pre-insertion disinfection step using Soto’s disclosed antiseptic dispensing capability. For example, after Harris identifies and verifies the target insertion site, the robot arm may position a housing or first aid module including an antiseptic solution and/or one or more antiseptic pads at the target area and execute a controlled wiping motion across the puncture zone, consistent with Soto’s disclosure that “the computer system may secrete the antiseptic solution and/or one or more antiseptic pads onto the target area to wipe and clean the target area on the user's arm” (Soto, Col. 2-3, ll. 61-33). After completing the wipe and clean action, the robot arm may then proceed to the needle insertion step at the same verified insertion site in the modified Harris’s workflow. The benefit of the combination would have been reduced infection risk and improved patient safety by ensuring consistent pre-insertion skin disinfection while maintaining Harris’s automated site selection and insertion control
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791