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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 11/10/2025. As directed by the amendment: claims 16, 18-20, and 22 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 16-25 are presently pending in this application. The 112(f) interpretation is maintained.
Response to Arguments
Applicant's arguments on p.1 of “Remarks,” filed 11/10/2025, with respect to the 102 rejection of Grober have been fully considered but they are not persuasive.
In response to applicant’s argument that Grober fails to disclose detecting the position of the clamping element in claim 16, the examiner respectfully disagrees. Applicant argues “instead, Grober discloses a measurement device 24 which is designed for measuring the inductance of a coil not for detecting the actual physical position of the clamping element.” Examiner disagrees as Grober discloses a measurement device 24 that measures the inductance of a coil which is a function of the actual physical position of the clamping element (19) and uses said inductance to deduce the actual physical position of the clamping element (19, see para. 0047-0049 and 0059). Further, examiner notes that the specification of the instant application discloses in para. 0057 “In particular, the position detector 20 is a sensor comprising a transmitter of a signal and a receiver of the signal transmitted. This sensor cooperates with the clamping element 5 to detect the position of said clamping element. This sensor is in particular a contactless sensor of the optical, inductive, capacitive, magnetic or ultrasonic type.” Thus, the instant application explicitly cites an inductive sensor as being an acceptable position detector. Further, the remaining contactless sensors recited in the specification all use contactless methods such as light, capacitance, magnetism, or ultrasonic energy which utilize these energies as functions of actual physical position. Thus, the 102 rejection of claim 16 in view of Grober is maintained.
In response, to applicant’s argument that Grober fails to disclose the position detector as sensor comprising a signal transmitter and a signal receiver that detects the position of the clamping element, the examiner respectfully disagrees. Examiner points to the discussion above indicating that Grober’s measurement device (24) does anticipate a position detector that is in the form of a sensor that can detect the position of the clamping element. Examiner further notes that said measurement device (24) does comprise a signal receiver in the form of a voltmeter (27) that receives voltage signals from a signal transmitter in the form of a voltage source (26) that transmits voltage signals (see para. 0052). Thus, the argument is not persuasive. However, in light of the amendments, examiner also has made a new grounds of rejection for claim 22 over Sala in view of Grober in view of Skog, wherein Skog teaches the limitations of claim 22.
Applicant’s arguments with respect to claim(s) 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 19, 21, and 24 are objected to because of the following informalities:
Regarding claim 19, the phrase “coupled to one end to the clamping element configured” in line 2 should read “coupled to one end of the clamping element and configured” for proper grammar,
Regarding claim 21, the phrase “claim 16n” in line 1 should read “claim 16,” to remove the “n” and add a comma,
Regarding claim 24, the phrase “closed position to prevent the signal receiver” in line 4 should read “closed position and to prevent the signal receiver” for proper grammar,
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 limitation(s) is/are:
A drive member in claim 19
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.
Regarding “a drive member” in claim 19, the specification is referenced for the corresponding structure. Specification para. 0041 discloses “for example. the drive member is a linear motor…, electro-magnet motor, a DC or AC motor, a brushless motor, or a pneumatic or hydraulic cylinder.” Examiner will be interpreting the drive member as the above structures or an equivalent.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 19, the limitation “the drive member being arranged to produce a movement of the drive member” is new matter. The disclosure does not have support for the drive member being arranged to produce a movement of said drive member. The specification discloses in para. 0041 and 0054 that the drive member is for example, a linear motor, electro-magnet motor, DC or AC motor, brushless motor, pneumatic or hydraulic cylinder or particularly, a stepper motor linear actuator of an anti-rotation system. Para. 0040 of the spec. states “a drive member 7 arranged to produce a movement and to transmit it to said clamping element 5.” Thus, there is no language in the specification that supports the drive member produces a movement of said drive member. Given that there is no support in the disclosure, it is new matter. Examiner notes this limitation is being interpreted as presented in the specification para. 0040 with the drive member arranged to produce a movement and transmit it to said clamping element.
Regarding claim 20, this claim is rejected due to its dependency upon claim 19.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the phrase “a flexible tube” in line 2 renders the claim indefinite because it is unclear. It is unclear whether this is a different flexible tube or the aforementioned one in claim 16. Examiner is interpreting it as the latter.
Regarding claim 19, the phrase “the drive member being arranged to produce a movement of the drive member” in lines 3-4 render the claim indefinite because it is unclear. It is unclear how the drive member can produce a movement of itself. The specification discloses in para. 0041 and 0054 that the drive member is for example, a linear motor, electro-magnet motor, DC or AC motor, brushless motor, pneumatic or hydraulic cylinder or particularly, a stepper motor linear actuator of an anti-rotation system; however, even with these examples it is still unclear how the drive member is producing a movement of itself. Examiner is interpreting this limitation as the drive member is arranged produce a movement and transmit it to the clamping element.
Regarding claim 20, the phrase “the clamping surface being displaced towards the bearing surface along an axis that is distinct from the axis wherein the body in the form of a plate is displace” in lines 4-6 renders the claim indefinite because it is unclear. It is unclear whether “the axis” is referring back to “an axis” or if this is a different axis that requires proper antecedent basis. Examiner is interpreting it as a different axis, and thus suggests amending “along an axis that is distinct from an axis wherein..”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-18 and 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Grober (U.S Patent Pub. No. 2020/0338332 A1).
Regarding claim 16, Grober discloses (Claim 16) a device (14) for clamping a flexible tube (6) and determining the presence of the flexible tube (6) in the device (14, see at least Fig. 1-8A and para. 0046-0048 and 0059 – apparatus 14 for clamping venous hose line 6 and determining state of apparatus 14 relative to the presence of the hose line 6), comprising:
a bearing element (15) comprising a bearing surface (18) configured to accept the flexible tube (6) for being clamped (see Fig.2 and para. 0047 – apparatus 14 comprises a housing body 15 with abutment surface 18),
a clamping element (19) comprising a clamping surface (distal end of 19) facing the bearing surface (18, see Fig. 2 and para. 0047 – apparatus 14 further comprises a clamping body 19 with a distal end being that faces the abutment surface 18), the clamping element (19) configured to move with respect to the bearing element (15) between at least one open position where the flexible tube (6) placed between the bearing surface (18) and the clamping surface (distal end of 19) is not deformed (see para. 0047 – clamping body 19 is actuated by an electromagnetic actuation unit 20 to move with respect to the housing body 15 and especially abutment surface 18, see Fig. 6 and para. 0055-0056 – Fig. 6 illustrates the first operating state where clamping body 19 assumes an open position and hose line 6 can be inserted into the apparatus 14, examiner is interpreting the open position as the state that occurs between the first operating state and second operating state when the clamping body 19 assumes an open position and hose line 6 is inserted into the apparatus 14), an obturation position where the flexible tube (6) placed between the bearing surface (18) and the clamping surface (distal end of 19) is obstructed and a closed position where the bearing surface (18) and the clamping surface (distal end of 19) are in contact (see Fig. 7 and para. 0056 – Fig. 7 illustrates the second operating state being interpreted as the obturation position where the clamping body 19 assumes the position where hose line 6 is inserted and clamped, see Fig. 8 and para. 0057 – Fig. 8 illustrates the third operating state being interpreted as the closed position where the clamping body 19 assumes a completely closed position in which hose line 6 is not inserted into the apparatus 14 and as illustrated the distal end of clamping body 19 and abutment surface 18 are in contact), and
a control unit (combined structure of 13 and 23) configured to implement the following operations (see para. 0047 and 0050-0051 – blood treatment apparatus may have a central and arithmetic unit 13 and apparatus 14 may comprise a monitoring device 23 comprises a measurement device 24 and evaluation device 25, examiner is interpreting the control unit as the combined structure of the control as the unit 13 and monitoring device 23 as they are in communication and together control aspects of the apparatus 14):
actuating the clamping element (19) from the open position towards the closed position until the clamping element (19) is blocked (see para 0047 – the electromagnetic actuation unit 20 for actuating the clamping body 19 is controlled by the central control and arithmetic unit 13),
detecting the position of the clamping element (19) as blocked with a position detector (22, see para. 0052 – measurement device 24 comprises a voltage source 26 that generates a voltage in coil 21 and is being interpreted as the signal transmitter and further comprises a voltmeter 27 for measuring the voltage and being interpreted as the signal receiver, see para. 0047-0049 and 0059– the measured inductance by the voltmeter is a function of the penetration depth d of the clamping element 19 and the monitoring unit 23 generates a signal assigned to the relevant operating state including the when the clamping element 19 is blocked),
determining the presence or the absence of the flexible tube (6) according to the position of the clamping element (19, see para. 0059 – evaluation device 25 of monitoring unit 23 generates signals assigned to the relevant operating state which correlate to the position of the clamping body 19 and thus determine if the hose line 6 is absent if the first or third operating state is detected and present if the second operating state is detected).
Regarding claim 17, Grober discloses (Claim 17) the device (14) according to claim 16, wherein the presence of the flexible tube (6) is determined if the position of the clamping element (19) detected is in the obturation position (see para. 0059 – presence of the hose line 6 is confirmed if the clamping body 19 is in the second operating state being interpreted as the obturation position), and wherein the absence of the flexible tube (6) being determined if the position of the clamping element (19) detected is in the closed position (see para. 0059 – absence of the hose line 6 is confirmed if the clamping body 19 is in the third operating state being interpreted as the closed position).
Regarding claim 18, Grober discloses (Claim 18) the device (14) according to claim 16, wherein the control unit (combined structure of 13 and 23) is configured to emit an alert signal in the case of absence of a flexible tube (6, see Fig. 2 and para. 0059 – monitoring device 23 of apparatus 14 comprises an alarm device 29 which emits an acoustic, visual, or tactile alarm when the hose line 6 is not inserted).
Regarding claim 21, Grober discloses (Claim 21) the device (14) according claim 16, further comprising a spring (22) arranged in an initial position to place the clamping element (19) in the closed position (see Fig. 8 and para. 0047 – clamping body 19 is resiliently biased towards the abutment surface 18 by compression spring 22, see Fig. 8 for the initial position of spring 22 when clamping body 19 is the third operating state being interpreted as the closed position).
Regarding claim 22, Grober discloses (Claim 22) the device according claim 16, wherein the position detector (24) is a sensor comprising a signal transmitter (26) and a signal receiver (27) that cooperates with the clamping element (19) to detect the position of the clamping element (19, see para. 0047-0049 and 0052 – measurement device 24 comprises a voltage source 26 that generates a voltage in coil 21 and is being interpreted as the signal transmitter and further comprises a voltmeter 27 for measuring the voltage which is a function of the penetration depth d of the clamping element wherein the voltmeter 27 is being interpreted as the signal receiver, thus the combined structure of the voltage source and voltmeter forms a sensor for detecting the position of the clamping element 19).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sala (U.S Patent Pub. 20190143012 A1) in view of Grober.
Regarding claim 16, Sala discloses the limitations of (Claim 16) device (22 in Fig. 1 and 8a-8c) for clamping a flexible tube and determining the presence of the flexible tube in the device (22, see Fig. 8a-8c and para. 0024), comprising:
- a bearing element (39 in Fig. 8a) comprising a bearing surface (proximal surface of 39) configured to accept the flexible tube for being clamped (see Fig. 8a and para. 0096),
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- a clamping element (40 in Fig. 8a) comprising a clamping surface (distal surface of 40) facing the bearing surface (proximal surface of 39, see annotated Sala drawing 1 below for surfaces), the clamping element (40) configured to move with respect to the bearing element (39) between at least one open position (Fig. 8a) where the flexible tube placed between the bearing surface (proximal surface of 39) and the clamping surface (distal surface of 40) is not deformed (see Fig. 8a and para. 0099), an obturation position (Fig. 8c) where the flexible tube placed between the bearing surface (proximal surface of 39) and the clamping surface (distal surface of 40) is obstructed (see Fig. 8c and para. 0101), and
- a control unit configured to implement the following operations (see para. 0097-0098 – the drive means comprises a control unit that commands the motor to change the position of the clamping element 40):
- actuating the clamping element (40) from the open position (Fig. 8a) until the clamping element (40) is blocked (see para. 0098),
- detecting the position of the clamping element (40) as blocked with a position detector (see para. 0102 – a detection sensor can be associated with the control unit to detect the degree of closure or opening of the slit 38 and thus detect the position of the clamping element 40).
While Sala discloses a device comprising a clamping element that can be actuated by a control unit from an open position to an obturation position and a position detector, Sala is silent to a closed position where the bearing surface and the clamping surface are in contact and the control unit determining the presence or the absence of the flexible tube according to the position of the clamping element.
Grober discloses a device (14) for clamping a venous hose line (6), wherein the device (14 in Fig. 6-8) comprises a clamping element (19) with a distal clamping surface and a control unit (13 and 23) for controlling the actuation of the clamping element (19) between an open position (Fig. 6), an obturation position (Fig. 7), and a closed position (Fig. 8, see para. 0047 and 0055-0058). Grober teaches (Claim 16) a closed position where the bearing surface (18) and the clamping surface (distal surface of 19) are in contact (see Fig. 8 and para. 0058), and the control unit (13 and 23) determining the presence or the absence of the flexible tube (6) according to the position of the clamping element (19, see para. 0059 – evaluation device 25 of monitoring unit 23 generates signals assigned to the relevant operating state which correlate to the position of the clamping body 19 and thus determine if the hose line 6 is absent if the first or third operating state is detected and present if the second operating state is detected).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Sala to have a closed position and a control unit that can determined the presence or absence of the flexible tube according to the position of the clamping element as taught by Grober. Grober teaches that having a third, closed position where the clamping element is in contact with the bearing element which provides a safety feature allowing the control unit and positioned detector to detect that there is no hose line inserted into the apparatus and an alarm can be emitted as the treatment may only be enabled if the hose line is enabled (see para. 0059).
Regarding claim 19, modified Sala (Claim 19) discloses the device according to claim 16, as discussed above. In modified Sala, Sala discloses (Claim 19) further comprising a drive member (“stepper motor” in para. 0097) coupled to one end to the clamping element (40) configured to linearly displace the clamping element (40, examiner notes the drive member is being interpreted under 112(f) as a linear motor, electro-magnet motor, a DC or AC motor, a brushless motor, or a pneumatic or hydraulic cylinder or equivalents thereof, see Fig. 8a-8c and para. 0097 – the clamping element 40 is linearly displaced as seen in Fig. 8a to 8c by a stepper motor which is an equivalent structure the motors listed above, examiner notes Fig. 8a-8c illustrate a shaft of the stepper motor that is coupled to a proximal end of the clamping element 40), the drive member (“stepper motor” in para. 0097) being arranged to produce a movement of the drive member (“stepper motor” in para. 0097) and transmit the movement of the drive member (“stepper motor” in para. 0097) to the clamping element (40) through the coupling (see para. 0097 – examiner notes a stepper motor produces movement of its shaft and this movement would transmit to the clamping element 40 through the coupling of the clamping element 40 with the shaft seen in Fig. 8a-8c).
Claim(s) 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Sala in view of Grober, as applied to claim 16 above, and in further view of Skog (U.S Patent No. 6189565 B1).
Regarding claim 22, modified Sala discloses the device according to claim 16, as discussed above. In modified Sala, Sala discloses the limitations (Claim 22) wherein the position detector is a sensor (see para. 0102).
However, modified Sala fails to explicitly disclose the sensor comprising a signal transmitter and a signal receiver that cooperates with the clamping element to detect the position of the clamping element.
Skog discloses a valve (1 in Fig. 1) with a movable element (5) that is actuatable to place the valve in an open position (see Fig. 1) or a closed position with respect to the fluid conduit (3, see Col.2, lines 54-65), wherein the valve (1) comprises a position detector (9 in Fig. 1) to sense the change in the position of the movable element (5, see Col.3, lines 3-7). Skog teaches (Claim 22) wherein the position detector (9 in Fig. 1) is a sensor comprising a signal transmitter (13 in Fig. 1) and a signal receiver (16 in Fig. 1) that cooperates with the movable element (5) to detect the position of the movable element (5, see Col.3, lines 10-35 – the sensor unit 9 comprises an LED 13 and a photodetector 16 that cooperate with the movable element 5 to determine its position).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and the position detector taught by modified Sala to have an opening in the clamping element and to have a signal transmitter and signal receiver in the casing as taught by Skog. Skog teaches using an optical position detector simply and directly monitors whether the valve is open or closed (see Col.2, lines 1-7). In combination, the LED (13) and the photodetector (16) of Skog would be incorporated into modified Sala such that an opening would be modified into the clamping element (40) of Sala with the photodetector and LED positioned on either side of said channel in the casing (39), and when light is received by the photodetector it indicates the clamping element (40) is in one position and when light is not received by the photodetector it indicates the clamping element (40) is displaced from said position.
Regarding claim 23, modified Sala discloses the device according to claim 22, as discussed above. In modified Sala, Skog discloses (Claim 23) wherein the sensor is in the form of an optical sensor (see Col.3, lines 10-35).
Regarding claim 24, modified Sala discloses the device according to claim 22, as discussed above. In modified Sala, Skog discloses (Claim 24) wherein the movable element (5) comprises an opening (6 in Fig. 1) configured to authorize the receiving by the signal receiver (16) of the signal transmitted by the signal transmitter (13) when the movable element (5) is in one position and to prevent the signal receiver (16) from receiving the signal transmitted by the signal transmitter (13) when the movable element (5) is in the other position (see Col.3, lines 10-35 – the movable element 5 comprises an opening 6 therethrough that authorizes the receiving of light by the photodetector when the movable element 5 is in the parallel position seen in Fig. 1 and prevents said receiving of light when the movable element 5 is in the perpendicular position).
In combination, the opening (6) of the movable element of Skog would be modified transversely across the clamping element (40) of modified Sala, and the LED (13) and the photodetector (16) of Skog would be modified into modified Sala such that they are positioned on either side of said opening in the casing (39). Thus, when the clamping element (40) is in the obturation position (see Fig. 8c), the photodetector and LED would align with the opening in the clamping element (40) and light would be transmitted therebetween. When, the clamping element (40) is in the closed position and is displaced due to no tube being present, the opening in the clamping element (40) would no longer be aligned with the LED and the photodetector and no light would be transmitted.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sala in view of Grober in view of Skog, as applied to claim 22 above, and in further view of Weatherbee et al. (U.S Patent Pub. No. 2010/0188667 A1, “Weatherbee”).
Regarding claim 25, modified Sala discloses the device of claim 22, as discussed above. However, modified Sala fails to disclose (Claim 25) wherein the sensor is in the form of a pair of sensors.
Weatherbee discloses a generic fluid control device for medical, pharmaceutical, bio-technology, and other applications comprising a pinch valve and an optical aperture sensor for determining the position of the pinch valve relative to the contacting surface. Weatherbee teaches (Claim 25) wherein the sensor (1300) is in the form of a pair of sensors (see Fig. 13-17 and para. 0262, 0267, and 0269 - optical aperture sensor 1300 is configured for detecting the position of moving solenoid armature relative to its contacting surface in a solenoid pinch valve 161 and comprises a light source 1304 as the signal transmitter and two photo receivers 1305 and 1309 as the signal receivers which cooperate with the moving solenoid armature through pin 1301 to determine the solenoid armatures position, examiner is interpreting the two photo receivers 1305 and 1309 and the light source 1304 which transmits signals to both receivers as the pair of sensors).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor taught by Skog to have two photo receivers to form a pair of sensors as taught by Weatherbee. The motivation for this modification is that Weatherbee teaches that a light source transmitting a signal to each of two receivers provides a main photo receiver and corrective photo receiver to help compensate for the effect of environment factors on electrical output from the main photo receiver and increase accuracy (see para. 0269).
Allowable Subject Matter
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C 112(a) and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Grober (U.S Patent Pub. No. 20200338332 A1), Sala (U.S Patent Pub. No. 20190143012 A1), and Archat et al. (W.O Patent Pub. No. 2019243010, “Archat”).
Grober discloses a clamping element (19) comprising a clamping surface (distal end of 19) and a bearing element (15) comprising a bearing surface (18) configured to accept a flexible tube (6), wherein the clamping element (19) is a plunger-like element actuated by an electromagnetic actuation unit (20) having a solenoid with a cylindrical hollow coil (21) and a compression spring (22) such that the clamping element (19) is configured to move with respect to the bearing element (15) between an open position (see Fig. 6 and para. 0055-0056) with the flexible tube (6) placed therebetween but not deformed, an obturation position (see Fig. 7) with the flexible tube (6) placed therebetween and obstructed, and a closed position (see Fig. 8) where the flexible tube (6) is absent and the two surfaces are in contact. Further, Grober discloses a control unit (“central and arithmetic unit 13” and “monitoring device 23” in Fig. 0047) which is configured to actuate the clamping element (19) by controlling the electromagnetic actuation unit (20, see para. 0047), detects the position of the clamping element (19) with a position detector (22) which is a combined voltage source (26) and voltmeter (27) measuring voltage which is a function of the penetration depth of the clamping element (19), and determines the presence or absence of the flexible tube (6) by using the generated voltage signals to determine if the clamping element (19) is in the obturation position indicating the tube is present or the positions seen in Fig. 6 and 8 indicating the tube is absent (see para. 0059). However, Grober fails to disclose the drive member as interpreted under 112(f) as a motor, hydraulic/pneumatic cylinder, or equivalent structure and the electromagnetic actuation unit (20) and solenoid are not equivalent structures. Further, the electromagnetic actuation unit (20) fails to disclose that it is able to move and thus transmit said movement to the clamping element (19) as the applied voltage from the solenoid is what is transmitted instead. Thus, Grober fails to disclose claims 19-20 and is not able to modified to have a drive member as claimed as it would render the original invention inoperable.
Sala discloses a clamp (22 in Fig. 8a-8c) comprising a clamping element (40) comprising a distal surface as the clamping surface and a bearing element (39) comprising a slit (38) with a proximal bearing surface configured to accept the tube (see para. 0096), wherein the clamping element (40) is movable by the drive of a stepper motor (see para. 0097) and moves with respect to the bearing element (39) between an open position (Fig. 8a) and an obturation position (see Fig. 8c and para. 0099 and 0101). The clamp (22) further comprises a detection sensor associated with the clamp (22) that detects the degree of closure or opening of the slit (38) and thus the position of the clamping element (40). Sala is silent to the clamping element having a closed position and is silent to a control unit carrying out the claimed operations of claim 22.
Sala in view of Grober would yield a clamp that can have a closed position and a control unit to determine the presence or absence of the tube in the clamp as discussed above in view of Grober.
Sala does disclose a drive member (“stepper motor” in para. 0097) housed inside the unit (13) and comprises a shaft coupled at one end to the clamping element (40) and produces a movement to move the shaft and thus linearly displace the clamping element (40) as claimed in claim 19, and Sala discloses the clamping element (40) coupled at a first end (proximal end of 40) to the drive member and comprising at a second end a curved portion ending with the clamping surface (see Fig. 8a – clamping element 40 at a distal end has a protruding curved portion forming a distalmost surface as the clamping surface). Further, Sala discloses that the clamping surface (distal surface of 40) being displaced towards the bearing surface (proximal surface of 39) along an axis that is distinct from an axis wherein the clamping element (40) is displaced (see Fig. 8a-8c – the shaft of the stepper motor displaces the clamping element 40 along a first axis and the distal end of the clamping element 40 comprising the curved protrusion is radially offset from this axis to the left-hand side forming a second, distinct axis for the clamping surface to be displaced). However, Sala fails to disclose the clamping element in the form of a plate with a spring positioned therein. There is no reference that teaches a clamping element in the form of a plate with a spring positioned therein that could modify the shape of the clamping element (40) of Sala to be a plate.
Archat discloses an infusion device (1 in Fig. 1) comprising a clamping mechanism (2 in Fig. 2-8) having a clamping element (20) with a clamping surface (205) which is movable with respect to a bearing element (21) having a bearing surface (212). The clamping element (20) is pivotably movable from the position seen in Fig. 2 to that of the obturation position seen in Fig. 4 which blocks the flexible tube (30). Archat fails to disclose a control unit that controls the movement of the clamping element (20) and rather discloses a lid (11) of the infusion device (1) that controls the position of the clamping element (20). Further, Archat fails to disclose the clamping element (20) being linearly displaced and rather discloses it being pivotally displaced. Examiner notes that Archat does disclose the clamping element (20) comprises a spring (204) positioned inside the body (20) with motivation for such a modification being that the spring allows for tolerances in the system and differences in the structural build and dimensions of different tubing to be compensated for and adjusted to (see p.11, para. 3). However, there is still no reference that teaches the full breadth of claim 20.
Therefore, there is no reference that teaches or discloses the limitations of claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783