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 .
Applicant' s arguments, filed 7/16/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 7/16/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
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 Claim 15 has been withdrawn; claim 2 has been canceled; and claims 1 and 3-14 are hereby under examination.
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 3: ”needle-holder" is inconsistent with "needle holder" used in claims 1, 3, 8, 11, and 13, and the terminology should be made consistent.
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. The claim limitations interpreted under 112(f) 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 rejection under 35 U.S.C. 112(b) 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 and the robotic arm and an electromechanical disarming system (or triggering system) when the needle is removed" (Instant Application ¶[0097]).The Specification also describes an embodiment in which "the movable portion being configured to be able to be moved, on command from a control unit and associated actuators, relative to the fixed portion in order to ensure the insertion/removal of the needle carried by the needle holder in the limb of the patient, 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 or 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 6. 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, such as 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 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: "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 which is in fluidic connection with the sampling needle. These means may also be formed by means for weighing the tube which enable the quantity of blood present in the tube to be determined from a knowledge of the empty weight of the tube. These means may also be formed by means for calculating the filling time which enable the quantity of blood present in the tube to be estimated from the puncture time and information representing the flow rate of the blood sampling operation. 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 rejection under 35 U.S.C. 112(b) 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 rejection under 35 U.S.C. 112(b) below.
Claim 13 recites "a system for disengaging the rotation of said needle” in lines 2-3. 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 which facilitates the insertion thereof into the patient's limb 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. The force of this spring, the tension thereof and the nature of the materials used are 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 a puncture zone of the patient's limb” 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: "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 a puncture zone of the patient's limb" 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.
Additional Claim Interpretation
Claim 8 recites "a movable part carrying at least said needle holder and said fluidic connection” in lines 3-4. For purposes of examination, the Examiner interprets "said fluidic connection" as referring to the entire fluidically connecting device recited in claim 1, including its motorized tube-loading and distributing structure. This interpretation is consistent with the Specification, which expressly states that the movable portion carries "the needle holder and the fluidic connection device" (Instant Application ¶[0041]-[0044], [0055], [0101]-[0105]).
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 teaching of “any type” does not convey any particular structure or structures and, in fact, provides no metes or bounds to the limitation. As a result, this limitation is not defined and therefore indefinite. 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. This rejection is related to the interpretation under 35 U.S.C. 112(f).
Claim 1 further recites "said fluidically connecting device being motorized and integrated within said blood puncture head, and further comprising a device for loading and distributing blood collection tubes” in lines 19-21. The participial phrase "and further comprising" lacks a clear grammatical referent (i.e., it is not clear what element further comprises a device for loading and distributing blood collection tubes). It is unclear whether the loading and distributing device is part of the fluidically connecting device, part of the blood puncture head generally, or a separate component introduced by the claim. For purposes of examination, the Examiner interprets the loading and distributing device as a component of the motorized fluidically connecting device integrated within the blood puncture head. This interpretation is consistent with the Specification's description of the tube-loading, tube-distributing, and tube-connecting components as parts of the fluidic connection device within the head (Instant Application ¶[0041]-[0044], [0055], [0101]-[0105]).
Claim 1 further recites the emergency removal limitation twice in immediate succession, without punctuation, a conjunction, or other connector between the clauses. The amended passage reads, in relevant part, "an exclusively mechanical removal of said needle from said patient's limb said electromechanical device being configured to allow, on command and including in the event of electrical power loss, an exclusively mechanical removal” (lines 29-32). It is unclear whether the two clauses define separate emergency removal operations or whether the second clause was intended to replace and further qualify the first clause. The absence of a connector and the duplication render the scope of the amended limitation uncertain. For purposes of examination, the Examiner interprets the two clauses as one emergency-removal limitation, with the second clause further defining the first to require the electromechanical device to release a mechanical biasing force that removes the needle on command, including upon electrical power loss, without electrical power being required for the removal movement.
Claims 3-14 are rejected by virtue of their dependence from claim 1.
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 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 mounted on said needle holder into a vein" as any sensor arrangement that detects venous entry based on a sensed condition associated with blood vessel access. This rejection is related to the interpretation under 35 U.S.C. 112(f).
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. This rejection is related to the interpretation under 35 U.S.C. 112(f).
Claim 13 is rejected by virtue of its dependence from claim 12.
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, 3, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke.
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); 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 teaches that the fluidically connecting device is motorized and includes the tube-loading and distributing components described above, but does not teach said fluidically connecting device being integrated within said blood puncture head. Harris's motorized automatic dispenser unit 74, manipulator 210, and lead screw driven carriage 70 receive and move collection tubes onto and away from piercing needle 72, but dispenser unit 74 is a machine-level unit separate from needle tool 3 (Harris ¶[0072]-[0076], [0083], [0091], FIGS. 16-19).
Jie teaches a self-contained multi-shot automatic blood collection gun having syringe 200 connected to blood collection needle 100 and tailstock 300 connected to the rear of the syringe. Clamping plate 303 is mounted within the tailstock and holds multiple blood collection tubes 500, while drive assemblies within the tailstock rotate the clamping plate and move it linearly. A selected tube is aligned with rear needle part 103, moved forward so rear needle part 103 enters the tube stopper, and moved backward to separate the tube from the rear needle (Jie ¶[0005], [0009], [0033]-[0038], [0047]-[0051], FIGS. 1 and 6-10).
Jie further teaches that clamping plate 303 may include multiple clamping holes or clamping cylinders 309 for receiving the tubes, that moving drive motor 414, lead screw 415, and guide rail 418 produce axial tube movement, and that rotary drive motor 419 indexes the selected tube. These tube receiving, selecting, connecting, and disconnecting components are installed in the tailstock of the same blood collection gun as the needle and therefore constitute a motorized fluidically connecting device integrated within the puncture instrument (Jie ¶[0036], [0038], [0047]-[0051]).
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 Jie by replacing Harris's remote tube-dispenser arrangement with Jie's self-contained needle cylinder, tailstock, clamping plate, tube receiving positions, rotary indexing drive, and axial tube connection drive mounted as part of Harris's needle tool 3, while retaining Harris's robotic tool changer and controlled needle-insertion movement. The resulting robotic end-effector would carry the needle holder and the tube loading, distribution, connection, and disconnection assembly within the same puncture head. Jie expressly teaches that its integrated arrangement permits multiple tubes to be filled through one puncture, avoids repeated manual tube changes and resulting disturbance of the inserted needle, and reduces direct contact with tubes and blood splash (Jie ¶[0004], [0016]-[0019], [0037]). The modification would have had a reasonable expectation of success because Harris expressly uses a modular tool changer to attach different procedure-specific tools, and both Harris and Jie connect evacuated collection tubes to a rear needle interface for venous blood collection. Jie's tube indexing and axial connection movements occur internally within its self-contained tailstock after the instrument is positioned, so mounting that assembly as Harris's needle tool would not require changing Harris's robotic site selection or insertion control (Harris ¶[0060], [0067], [0076]).
Also regarding claim 1, the modified Harris does not fully teach an electromechanical device for disarming the head and emergency removal of said needle from said patient's limb configured to allow, on command and including in the event of electrical power loss, an exclusively mechanical removal of said needle from said patient's limb by a mechanical biasing force acting without requiring any electrical power supply. Harris includes emergency stop and extraction commands, but does not expressly teach a spring or other mechanical biasing member that automatically removes the needle when electrical power is lost (Harris ¶[0041], [0109], [0113]).
Overbeeke teaches a cannula insertion device 8 supported by positioning system 9, which may be a robot arm, for inserting a cannula into a blood vessel. The device includes linear insertion guide 8c and biasing element 8d, such as a spring, that biases cannula 2 toward a retracted position. If linear insertion actuator 8a fails due to a power outage, the spring automatically pulls the cannula out of the body without electrical power (Overbeeke ¶[0103]-[0105]).
Overbeeke further teaches a power-outage retraction embodiment in which stop element 32 is connected to cannula 2 and slides along linear guide 31, spring element 33 biases the stop element and cannula toward the retracted position, and electrically operated blocking devices 50 hold the stop element only while energized. When the blocking devices are de-energized, including by loss of power, spring element 33 moves the stop element and cannula to the retracted position. Overbeeke also teaches control-commanded shutoff of the insertion actuator when an unsafe condition is detected, allowing the same mechanical bias to retract the cannula (Overbeeke ¶[0148], [0150]-[0154], Fig. 7).
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 Overbeeke by providing an electrically held, spring-biased retraction mechanism in the puncture head, with the spring acting on the needle-carrying portion and configured to retract that portion when the electrical holding device is de-energized by command or power loss. Overbeeke concerns robot-positioned vascular insertion and blood drawing and expressly identifies automatic withdrawal during a power outage as a patient-safety function (Overbeeke ¶[0059]-[0066], [0103]-[0105], [0150]-[0154]).The modification would have had a reasonable expectation of success because Harris and Overbeeke both advance a needle or cannula along a linear guide in a robot-positioned venous-access device, and Overbeeke demonstrates that the mechanical bias and energized holding structure operate on the linearly movable needle-connected member. Adding the spring and energized holding device to Harris's guided needle carriage would preserve the same insertion axis and would not alter Jie's internal tube-indexing operation. The benefit would have been reliable removal of the needle during an emergency or power interruption without depending on powered robotic retreat.
Regarding claim 3, the modified Harris further teaches that said device for loading and distributing collection 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, and 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. As shown above in claim 1, Jie’s clamping plate 303 constitutes the claimed barrel because it is a rotary tube carrier having multiple tube-receiving housings distributed around its central rotation axis. Specifically, clamping holes or clamping cylinders 309 are evenly distributed around the circumference of plate 303 at a common radial distance from that axis. The equality of the two claimed distances is implicit in this disclosed geometry because a tube carried at radial distance R from the rotation axis of plate 303 can be brought by rotation into axial alignment with rear needle part 103 only when the rear needle axis is offset from the plate's rotation axis by that same distance R. The plate rotates about an axis parallel to rear needle part 103 and successively brings each tube into axial alignment with the rear needle. Moving drive motor 414, lead screw 415, and guide rail 418 then move the aligned tube linearly onto the rear needle and subsequently away from it (Jie ¶[0036]-[0038], [0047]-[0051], FIGS. 1, 6, and 9-10).
Regarding claim 8, the modified Harris does not fully teach that said frame comprises a fixed part fitted with means for removable fixing to said mechatronic assembly and a movable part carrying at least said needle holder and said fluidic connection. Rather, Harris's female tool changer 10 and stationary body of needle tool 3 provide a fixed robotic attachment portion, Harris's needle gripper assembly 200 moves relative to that portion along guide rails 45, and Jie's complete motorized tube-loading and connecting assembly is incorporated into the same needle tool as described for claim 1. However, the modified Harris does not expressly teach a single movable part carrying both the needle holder and the entire fluidically connecting device (Harris ¶[0039], [0067], [0071]; Jie ¶[0033]-[0038])
Overbeeke teaches a fixed cannula insertion device 8 carrying linear guide 31 and movable stop element 32 connected to cannula 2. The cannula includes proximal connection device 2b and connection port 2c for connection to a blood collection tube or container, so Overbeeke moves the needle and its proximal connection together during retraction (Overbeeke ¶[0108], [0150]-[0152], Fig. 7).
It would have been prima facie obvious to mount Jie's assembled blood-collection instrument, including syringe 200, blood collection needle 100 and rear needle part 103, tailstock 300, clamping plate 303, and the rotary and moving drive assemblies, together with the needle holder, on Overbeeke's movable needle-connected element so that the needle and the entire fluidically connecting device retract relative to Harris's fixed robotic attachment portion. Jie already connects these components as one instrument and performs tube indexing and axial tube connection internally within tailstock 300. The proposed modification therefore does not create a new common subassembly or redesign Jie's tube-handling end-effector. It adds Overbeeke's guide, movable element, spring, and energized holding device to an assembly that already exists and operates as a unit. Moving the assembled instrument together would preserve the coaxial relationship among the needle, rear needle interface, tailstock, and tube-handling mechanism and would avoid separating or mechanically loading those connections during emergency withdrawal (Jie ¶[0033], [0038]; Overbeeke ¶[0108], [0150]-[0152]). There would have been a reasonable expectation of success because the added retraction is a common external translation along Overbeeke's guide and does not change the relative geometry or the internal rotary and axial tube-indexing movements within Jie's instrument. Overbeeke demonstrates spring retraction of a needle-connected movable element along a linear guide. Selecting a spring force and guide capacity sufficient for the known carried mass and required withdrawal travel would have been routine engineering optimization of workable operating parameters. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Also regarding claim 8, the modified Harris does not fully teach 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 said movable part of said frame toward the fixed part of said frame when said electromagnet is no longer supplied with current. Rather, the modified Harris includes Overbeeke’s spring element 33 extending between the fixed guide structure and movable stop element 32 and biasing movable stop element 32 toward retraction, while electrically operated blocking devices 50 hold the stop element only while energized and release it when no longer supplied with energy. However, the modified Harris does not expressly identify blocking devices 50 as electromagnets. (Overbeeke ¶ [0150]-[0154], Fig. 7.)
Overbeeke further teaches an electromagnet as a holding device having a magnetized holding state and a non-magnetized release state. (Overbeeke ¶ [0140], [0141].)
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 by using Overbeeke’s expressly disclosed electromagnet to implement the electrically operated blocking function of devices 50. Both structures perform the same holding and release functions by holding a movable member while energized and releasing the member when de-energized. The substitution would therefore have been a predictable use of a known electrical holding actuator and would have preserved the intended fail-safe operation in which loss of current releases the spring-biased movable member. There would have been a reasonable expectation of success because Overbeeke expressly demonstrates an electromagnet operating between magnetized holding and non-magnetized release states.
Regarding claim 9, the modified Harris does not fully teach means for determining the filling level of the collection tube in fluidic connection with said sampling needle. Rather, the modified Harris includes Jie's integrated tailstock, tube-receiving positions, rotary indexing drive, and axial tube-connection drive as described for claim 1 above, but does not expressly include a sensor arrangement for determining the amount of blood collected in the currently connected tube.
Jie teaches a liquid-volume detection module disposed on the inner wall of tailstock 300 and configured to determine whether the amount of blood collected in the current collection tube has reached a preset volume. Jie teaches that the liquid-volume detection module may be an infrared detection module, a pressure detection module, or another detection module. Jie's infrared detection module is an optical sensor arrangement corresponding to the disclosed optical means for determining the filling level of the collection tube (Jie ¶[0006], [0020], [0055]).
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 Jie by providing Jie's liquid-volume detection module and its signaling connection to the control module within the integrated tailstock to determine whether the amount of blood collected in the currently connected tube has reached a preset volume. Jie expressly teaches using the liquid-volume detection module in the same integrated multi-tube blood-collection arrangement relied upon for claim 1. The modified Harris already incorporates Jie's tailstock, collection-tube receiving positions, rotary indexing drive, axial tube-connection drive, and associated control arrangement. Providing Jie's expressly disclosed detector within that tailstock would therefore have predictably allowed the system to determine when the tube being filled by the sampling needle had collected the intended volume. There would have been a reasonable expectation of success because Jie mounts the detection module on the inner wall of tailstock 300 where it can monitor the collection tubes handled by the rotary and axial drive assemblies. Incorporating the detector would not require changing the needle interface, tube-indexing geometry, or axial tube-connection operation already incorporated into the modified Harris. The benefit would have been improved sample-volume control and automation by allowing the system to determine when a desired quantity of blood had been collected in the current tube.
Regarding claim 10, the modified Harris, as further modified for claim 9 above, further teaches that said means for determining the filling level of the collection tube are configured to be able to trigger an automatic change of the collection tube. As shown above, Jie teaches that when the collected volume reaches the preset value, the liquid-volume detection module signals the control module. In response, the control module causes the moving drive motor to disconnect the current collection tube from the rear needle and causes the rotary drive motor to rotate the clamping plate to align the next collection tube with the rear needle. Jie's filling-level detection means therefore generates the control signal that initiates the automatic replacement of the currently connected tube with another collection tube (Jie ¶[0020], [0054], [0055]). This triggering operation is part of the same liquid-volume detector, control module, and motorized tube-handling arrangement incorporated into the modified Harris for claim 9.
Regarding claim 11, the modified Harris further teaches 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 that 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).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke, 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), hereinafter Scientific Industries.
The modified Harris teaches claims 1 and 3 as described above.
Regarding claim 4, the modified Harris does not fully teach that said housings for receiving the collection tubes formed at the periphery of said loading and dispensing barrel comprise loops for clipping said tubes. Rather, the modified Harris via Jie teaches clamping holes or clamping cylinders 309 distributed around the periphery of clamping plate 303 and an elastic plug for retaining a tube within each housing, but does not expressly characterize those housings as loops for clipping the tubes (Jie ¶[0036], FIGS. 6 and 10).
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 by forming Jie's peripheral tube housings as resilient loop or clip structures. This would have been a predictable substitution of one known tube-retaining structure for another because Jie already arranges cylindrical tubes at peripheral receiving positions on a rotary plate, and Scientific Industries shows a circular plate using peripheral plastic clips to retain tubes in the same radial arrangement. The substitution would not change Jie's tube indexing or axial connection operation and would have improved retention during rotation and translation while permitting ready tube loading and removal.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and in view of Overbeeke et al. (US 2022/0054062 A1), and further in view of Soto (US 8,888,714 B1), hereinafter Soto, and further in view of Whitby (US 2002/0088553 A1), hereinafter 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, and 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 a puncture zone of the patient’s limb 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 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke, and further in view of Soto (US 8,888,714 B1), hereinafter Soto, and further in view of Whitby (US 2002/0088553 A1), hereinafter Whitby, and further in view of Zheng et al. (CN 110934687 A), hereinafter Zheng.
The modified Harris teaches claims 1 and 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 teaches the suction cup plate and automated dressing placement during withdrawal of the needle as described for claim 5, but does not teach a recess in the suction cup plate that allows passage of the needle during fitting of the dressing.
Zheng teaches a puncture-site dressing assembly configured to be fitted while the puncture needle remains present. Base 12 includes opposed lugs 17 having aligned needle-handle fixing holes 18, and the medical adhesive patch includes a nonadhesive path where the patch contacts the needle so that the needle can subsequently be withdrawn. Zheng expressly teaches positioning medical cotton 14 over the puncture hole and receiving the puncture needle assembly in fixing holes 18 before removal. The aligned needle-receiving openings and nonadhesive needle path therefore provide clearance for the needle while the dressing is positioned at the puncture site (Zheng, ¶[0008], [0014], [0046], [0057]).
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 by providing a recess or open slot in the suction cup plate corresponding to Zheng’s needle-receiving clearance so that the plate could fit the dressing at the puncture zone while the needle assembly remained present. Zheng teaches accommodating and temporarily fixing the needle during dressing placement to prevent movement of the needle and improve safety (Zheng ¶[0046]). This modification would have been a predictable structural adaptation of the dressing-holding and applying mechanism already taught by Soto and Whitby and would not have changed the principle of operation of the automated blood-draw device. The suction openings could have remained distributed over the plate area surrounding the recess, thereby preserving vacuum retention while providing clearance for the needle. There would have been a reasonable expectation of success because the recess would have altered only a limited portion of the suction cup plate while leaving sufficient surrounding plate area to retain the dressing by suction. The benefit would have been reduced snagging and interference and more consistent dressing placement during withdrawal.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke, and further in view of Soto (US 8,888,714 B1), hereinafter Soto, and further in view of Whitby (US 2002/0088553 A1), hereinafter Whitby, and further in view of Hellmer (US 4,359,314 A), hereinafter Hellmer.
The modified Harris teaches claims 1 and 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 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke, and further in view of Glozman et al. (US 2020/0179066 A1), hereinafter Glozman.
The modified Harris teaches claims 1 and 12 as described above.
Regarding claim 13, the modified Harris does not fully teach that said needle holder further comprises a system for disengaging the rotation of said needle so as to allow rotation of the needle on itself in order to be able to orient the bevel of 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 2012/0190981 A1), hereinafter Harris, in view of Jie (CN 109381199 A), hereinafter Jie, and further in view of Overbeeke et al. (US 2022/0054062 A1), hereinafter Overbeeke, and further in view of Soto (US 8,888,714 B1), hereinafter Soto.
The modified Harris teaches claim 1 as described above.
Regarding claim 14, the modified Harris does not fully teach means for the automatic disinfection of a puncture zone of the patient's limb. 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.
Response to Arguments
Objections
Applicant's arguments filed 7/16/2026, pages 13-15, regarding the previous objections of claims 3, 4, 5, 8, 10, 12, 13, and 14 have been fully considered and are persuasive in part. The objections to claims 3, 4, 5, 8, 10, 13, and 14 are withdrawn. The objection to claim 12 is maintained because the pending claim continues to use "needle-holder" while claims 1, 3, 8, 11, and 13 use "needle holder”.
35 U.S.C. §112(f)
Applicant's arguments filed 7/16/2026, pages 17-18, regarding the previous interpretations of claims 11 and 12 under 35 U.S.C. § 112(f) have been fully considered but are not persuasive. The interpretations of claims 11 and 12 under 35 U.S.C. § 112(f) are maintained as discussed below. Additionally, the interpretations of claims 1, 8, 9, 13, and 14, which Applicant did not substantively address, are also maintained.
Applicant's Argument: Applicant argues that the Specification sufficiently supports claim 11's means for detecting entry of the needle into a vein and each of claim 12's screwing, clipping, and magnetization alternatives. Applicant states that clipping is described at page 13 by "clip-fitting or magnetization of the sampling needle on the needle holder."
Examiner's Response: The argument is not persuasive as to claim 11 or the magnetization alternative of claim 12. For claim 11, the passage identified by Applicant states the detecting function but does not identify a sensing structure, sensing modality, or operational mechanism clearly linked to that function. The optical means cited by Applicant are disclosed for detecting blood in a collection tube to determine tube filling, not for detecting entry of the needle into a vein. For claim 12, Applicant's express characterization of page 13 confirms that clipping is described as a fastening alternative. Consistent with the previous Office Action, the Specification is treated as describing example structure for fixing the needle by screwing and/or clipping. Merely naming magnetization, however, does not provide corresponding magnetic structure or explain how magnetization performs the fixing function. The interpretations under 35 U.S.C. 112(f) are therefore maintained. Applicant did not substantively address the separate lack of corresponding structure for claim 1's "means for removably fixing the frame to said mechatronic assembly."
35 U.S.C. §112(b)
Applicant's arguments filed 7/16/2026, pages 15-17, regarding the previous rejections of claims 1 and 3-14 under 35 U.S.C. § 112(b) have been fully considered and are persuasive in part. The claim 10-specific rejection concerning “triggering” and inconsistent tube terminology is withdrawn. The rejections of claims 1, 3-9, and 10-14 under 35 U.S.C. § 112(b) are maintained as discussed below (Claim 10 remains rejected under 35 U.S.C. 112(b) by virtue of its dependence from claim 1).
Applicant's Argument: Applicant argues that an electromechanical device may produce an exclusively mechanical withdrawal, that amended claim 5 identifies the relationship among the suction cup plate, dressing, and hollow shaft, and that claims 11 and 12 are sufficiently supported by the passages cited in the Remarks.
Examiner's Response: The argument is persuasive in part. Applicant's explanation is persuasive that an electromechanical assembly may release a mechanical biasing force that performs withdrawal without electrical power, and the previous rejection of claim 1 based on an asserted inconsistency between "electromechanical" and "exclusively mechanical" is withdrawn. The amended claim 1, however, introduces the separate grammatical and duplicated-clause ambiguities identified above. The rejection of claim 1 concerning the means for removably fixing the frame is maintained because the Specification does not clearly identify corresponding structure for that function.
Although Applicant states that claim 5 was amended to clarify the relationship among the suction cup plate, the dressing, and the hollow shaft, the language underlying the rejection was not amended. Claim 5 continues to recite “a suction cup plate for holding a dressing carried by a hollow shaft pivoting relative to said frame,” which is identical to the language addressed in the previous Office Action. The amendment concerning the puncture zone does not resolve whether “carried by a hollow shaft” modifies the dressing, the suction cup plate, or both. Applicant’s explanation of its intended meaning in the Remarks does not alter the language of the claim. Accordingly, the rejection is maintained.
For the reasons stated in the 35 U.S.C. 112(f) response above, the claim 11 rejection is maintained because the Specification does not clearly link corresponding structure to the venous-entry detecting function. The claim 12 rejection is maintained as to the magnetization alternative only because the Specification does not disclose corresponding magnetic structure. Claim 13 remains rejected by virtue of its dependence from claim 12. The previous claim 10-specific rejection concerning “triggering” and inconsistent tube terminology is withdrawn. Claim 10 remains rejected under 35 U.S.C. 112(b) by virtue of its dependence from claim 1.
35 U.S.C. §112(d)
Applicant's arguments filed 7/16/2026, page 15, regarding the previous rejection of claims 3 and 4 under 35 U.S.C. § 112(d) have been fully considered and are persuasive. The rejections of claims 3 and 4 under 35 U.S.C. § 112(d) is withdrawn.
35 U.S.C. §103
Applicant's arguments filed 7/16/2026, pages 18-26, regarding the previous rejections of claims 1 and 3-14 under 35 U.S.C. § 103 have been fully considered and are persuasive in part. The previous rejections based on Harris in view of Wei, Harris in view of Wei and Balter, and the combinations dependent therefrom are withdrawn. Claims 1 and 3-14 remain rejected under 35 U.S.C. § 103 based on the presently stated grounds, as discussed below.
Applicant's Argument: Applicant argues that Harris's needle tool 3 and automatic dispenser unit 74 are separate subsystems and that Harris's modular, interchangeable tool architecture teaches away from integrating the motorized tube-loading and distributing device within the blood puncture head.
Examiner's Response: The argument is persuasive to the extent that Harris alone does not disclose the newly claimed integration, but it does not overcome the present rejection. The present rejection relies on Jie, not Harris, for the integrated arrangement. Jie discloses syringe 200, blood collection needle 100 and rear needle part 103, tailstock 300, clamping plate 303, and the tube-indexing and tube-connection drives as one assembled blood-collection instrument. Harris's tool changer provides a known interface for attaching a procedure-specific needle tool to robot arm 1. Mounting Jie's assembled instrument as that needle tool uses, rather than defeats, Harris's modular interface. Harris does not criticize, discredit, or discourage using an integrated procedure-specific end-effector. A disclosure of a modular architecture does not teach away from a particular tool configuration merely because other configurations are also possible. See In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994); In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant's Argument: Applicant argues that Harris paragraphs [0041], [0109], and [0113] disclose only a powered emergency stop or commanded robotic retreat and do not disclose passive mechanical needle withdrawal upon loss of electrical power.
Examiner's Response: The argument is persuasive as to the previous characterization of Harris, and that characterization is withdrawn. The present rejection does not rely on Harris for passive power-loss withdrawal. Overbeeke expressly teaches a spring that biases the cannula toward retraction and an electrically operated blocking device that holds the cannula in the insertion position only while energized. Upon power loss, the blocking device releases and the spring withdraws the cannula without electrical power. Overbeeke further identifies automatic withdrawal during a power outage as the purpose of the arrangement (Overbeeke ¶[0103]-[0105], [0150]-[0154]).
Applicant's Argument: Applicant argues that Wei is non-analogous art directed to a wearable subcutaneous drug-delivery patch and that incorporating Wei's retraction arrangement into Harris would require a fundamental redesign of Harris's robotic end-effector.
Examiner's Response: The argument is moot because Wei is no longer relied upon. The present rejection applies Overbeeke, which concerns robot-positioned vascular access and blood drawing and expressly addresses automatic cannula withdrawal in a power outage. The present claim 8 modification also does not require the redesign attributed to the former Harris-Wei combination. Jie already provides the syringe, rear needle interface, tailstock, tube carrier, and drives as one assembled instrument, with tube indexing occurring internally. The proposed modification adds Overbeeke's guide, movable element, spring, and energized holding device to that existing assembly so that it translates as a unit. It does not recreate or rearrange Jie's internal end-effector mechanism.
Applicant's Argument: Applicant argues that the stated safety rationale merely restates a benefit disclosed by Applicant and that the combinations are therefore based on hindsight.
Examiner's Response: The argument is not persuasive as to the present rejections. The reasons for the modifications are drawn from the applied references. Jie expressly teaches that its integrated multi-tube instrument permits collection into multiple tubes through one puncture, avoids repeated manual tube changes and disturbance of the inserted needle, and reduces direct contact with tubes and blood splash (Jie ¶[0004], [0016]-[0019], [0037]). Overbeeke expressly teaches automatic cannula withdrawal during a power outage as a patient-safety function (Overbeeke ¶[0103]-[0105], [0150]-[0154]). The further common-carriage modification preserves the alignment of Jie's already assembled needle and tube-handling instrument while applying Overbeeke's known fail-safe translation. These reasons arise from the prior art and ordinary mechanical consequences of the proposed combination, not from Applicant's disclosure.
Applicant's Argument: Applicant argues that corresponding patents were granted in France and Europe over Harris and related art and that those grants support patentability of the pending claims.
Examiner's Response: The argument is not persuasive. Patentability in this application is determined under United States law on the claims and evidence of record in this application. The allowance of a foreign counterpart under a different statutory framework and examination record is not binding on the Office. In addition, the present rejections apply Jie and Overbeeke for the amended integration and power-loss limitations, and Applicant has not shown that those grounds were considered in the cited foreign proceedings.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to AARON MERRIAM whose telephone number is (703) 756-
5938. The examiner can normally be reached M-F 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing
using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Jason Sims can be reached on (571)272-4867. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained
from Patent Center. Unpublished application information in Patent Center is available to
registered users. To file and manage patent submissions in Patent Center, visit:
https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for
more information about Patent Center and https://www.uspto.gov/patents/docx for
information about filing in DOCX format. For additional questions, contact the Electronic
Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO
Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights