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 .
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-11, drawn to a capacitive sensor.
Group II, claim 12, drawn to an irrigation system for bowel irrigation.
Group III, claim 13, drawn to a method of manufacturing an irrigation system
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a capacitive sensor assembly comprising a printed circuit board comprising an interior edge defining a passage for the tubing, the interior edge being configured to at least partly abut the tubing; a capacitive proximity sensor module; a conductive sensor face coupled to the capacitive proximity sensor module; and a conductive ground face electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor; wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Shea (US 3,553,575). Shea teaches a capacitive sensor assembly comprising a printed circuit board 10 (alternatively elements 24a, 24b, 22 could be construed as a circuit board with edge closest to element 26 allowing passage for the tubing) comprising an interior edge (interior edge of element 26) defining a passage for the tubing (column 2, lines 28-30), the interior edge being configured to at least partly abut the tubing (figure 2); a capacitive proximity sensor module 22; a conductive sensor face 24b coupled to the capacitive proximity sensor module; and a conductive ground face 24a electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor (figure 4); wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage (column 2, lines 65-70).
Groups II and III lack unity of invention because even though the inventions of these groups require the technical feature of a capacitive sensor assembly comprising a printed circuit board comprising an interior edge defining a passage for the tubing, the interior edge being configured to at least partly abut the tubing; a capacitive proximity sensor module; a conductive sensor face coupled to the capacitive proximity sensor module; and a conductive ground face electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor; wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Shea (US 3,553,575). Shea teaches a capacitive sensor assembly comprising a printed circuit board 10 (alternatively elements 24a, 24b, 22 could be construed as a circuit board with edge closest to element 26 allowing passage for the tubing) comprising an interior edge (interior edge of element 26) defining a passage for the tubing (column 2, lines 28-30), the interior edge being configured to at least partly abut the tubing (figure 2); a capacitive proximity sensor module 22; a conductive sensor face 24b coupled to the capacitive proximity sensor module; and a conductive ground face 24a electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor (figure 4); wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage (column 2, lines 65-70).
Groups I and III lack unity of invention because even though the inventions of these groups require the technical feature of a capacitive sensor assembly comprising a printed circuit board comprising an interior edge defining a passage for the tubing, the interior edge being configured to at least partly abut the tubing; a capacitive proximity sensor module; a conductive sensor face coupled to the capacitive proximity sensor module; and a conductive ground face electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor; wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Shea (US 3,553,575). Shea teaches a capacitive sensor assembly comprising a printed circuit board 10 (alternatively elements 24a, 24b, 22 could be construed as a circuit board with edge closest to element 26 allowing passage for the tubing) comprising an interior edge (interior edge of element 26) defining a passage for the tubing (column 2, lines 28-30), the interior edge being configured to at least partly abut the tubing (figure 2); a capacitive proximity sensor module 22; a conductive sensor face 24b coupled to the capacitive proximity sensor module; and a conductive ground face 24a electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor (figure 4); wherein the capacitive proximity sensor module, the sensor face and the ground face are arranged on the PCB and configured to measure the one or more capacitive characteristics of a medium in a tubing arranged in the passage (column 2, lines 65-70).
During a telephone conversation with Ethan Bell on 9/2/2026 a provisional election was made without traverse to prosecute the invention of Group II, claim 12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-11 and 13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant further decided to add new claims depending upon claim 12.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 12 and 14-23 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 12, the recitation “an irrigation liquid” in line 15 renders the claim indefinite because the claim is unclear if “an irrigation liquid” recited in line 15 refers to “a fluid” recited in line 2 or additional. For examination purposes, examiner construes “an irrigation liquid” in line 15 as being referring to “a fluid” recited in line 2.
Regarding claim 12, lines 31-32, the recitation “a fluid” renders the claim indefinite because the claim is unclear if “a fluid” refers to “a fluid” recited in line 2 or “an irrigation fluid” recited in line 15 or additional. For examination purposes, examiner construes that “a fluid” in lines 31-32 refers to “a fluid” recited in line 2.
Claims 14-23 being dependent on claim 12 are also rejected.
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 12 and 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 9,327,072 B2) in view of Shea (US 3,553,575) and further in view of Tolsa et al. (US 9,784,596 B2).
Regarding claim 12, Zhang discloses an irrigation system 10 (figure 1) for bowel irrigation comprising a capacitive sensor assembly 28 (column 3, lines 15-22) for measuring one or more capacitive characteristics of a fluid in a tubing 20 of the irrigation system, the irrigation system 10 further comprising:
a housing (housing of element 22) comprising a reservoir 22 for containing an irrigation liquid (liquid inside element 22);
the tubing 20 providing fluid communication between the reservoir 22 and a catheter 25 for use with the irrigation system;
a control unit 32 comprising a processor (column 3, lines 3-12) coupled to the capacitive sensor assembly 28; and
a pump 26 for facilitating a flow of irrigation liquid from the reservoir 22, through the tubing 20, to the catheter 25; and
the capacitive sensor assembly 28 comprising an assembly interface (interface shown in figure 3) for connection to the irrigation system and further comprising:
a circuitry (column 3, lines 36-45, “circuitry”) and an interior edge (edge of elements 42a, 42b) defining a passage (opening between elements 42a, 42b for the tubing 20, the interior edge (edge of elements 42a, 42b) being configured to at least party abut the tubing 20; a capacitive sensor module (module formed by elements 42a, 42b, lead wires connecting to the circuitry recited in column 3, lines 36-45), two conductive face 42a, 42b arranged and facing against each other to form a two-plate capacitor (figure 4); wherein the capacitive sensor module, the conductive faces are arranged on the circuitry and configured to measure the one or more capacitive characteristics of a fluid in the tubing (column 3, lines 15-22); and wherein the tubing 20 is arranged in the passage (opening between elements 42a, 42b) of the capacitive sensor assembly (figure 3).
Zhang is silent regarding a circuit board comprising an interior edge defining a passage for the tubing, a capacitive proximity sensor module; a conductive sensor face coupled to the capacitive proximity sensor module; and a conductive ground face electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor; wherein the capacitive proximity sensor module, the sensor face, and the ground face are arranged on the circuit board.
However, Shea teaches a design of a capacitive sensing device comprising a circuit board 10 comprising an interior edge (interior edge of element 26) defining a passage for the tubing (column 2, lines 28-30), a capacitive proximity sensor module 22; a conductive sensor face 24b coupled to the capacitive proximity sensor module 22; and a conductive ground face 24a electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor (figure 2); wherein the capacitive proximity sensor module 22, the sensor face 24b and the ground face 24a are arranged on the circuit board for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the capacitive sensor assembly of Zhang to incorporate a circuit board comprising an interior edge defining a passage for the tubing, a capacitive proximity sensor module; a conductive sensor face coupled to the capacitive proximity sensor module; and a conductive ground face electrically grounded relative to the capacitive proximity sensor module and arranged facing the sensor face to form a two-plate capacitor; wherein the capacitive proximity sensor module, the sensor face, and the ground face are arranged on the circuit board as taught by Shea for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Zhang is further silent regarding a circuit board being a printed circuit board.
However, Tolsa teaches a design of a capacitor sensor (figure 1b) comprising a printed circuit board (figure 2a) for the purpose of using a well-known form of a circuit board (column 2, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the circuit board of Zhang to incorporate a printed circuit board as taught by Tolsa for the purpose of using a well-known form of a circuit board (column 2, lines 10-13).
Regarding claim 14, Zhang discloses wherein the interior edge (edge of elements 42a, 42b) is electrically conducting in a first part (part where element 42a is present) and in a second part (part where element 42b is present) separate from the first part (part where element 42a is present).
Regarding claim 15, Zhang is silent regarding wherein the first part of the interior edge forms the sensor face, and wherein the second part of the interior edge forms the ground face.
However, Shea teaches wherein the first part (part of element 24b) forms the sensor face 24b, and wherein the second part (part of element 24a) forms the ground face 24a for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second parts of Zhang to incorporate wherein the first part of the interior edge forms the sensor face, and wherein the second part of the interior edge forms the ground face as taught by Shea for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Regarding claims 16 and 17, Zhang is silent regarding wherein the passage is a through-going opening in the PCB wherein the through-going opening is circular.
However, Shea teaches wherein the passage 26 is a through-going opening in the circuit board 10 wherein the through-going opening 26 (figure 2) is circular for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Zhang modified in view of Shea and Tolsa, as explained in the rejection of claim 12 above will result in having PCB.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the capacitive sensor assembly of Zhang to incorporate wherein the passage is a through-going opening in the PCB wherein the through-going opening is circular as taught by Shea for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Regarding claims 18 and 19, Zhang is silent regarding wherein the sensor face and the ground face are semicylindrical faces on the interior edge wherein each of the first part and the second part of the interior edge is configured to abut the tubing in arc less than 1700.
However, Tolsa teaches wherein the sensor face 22, 23 (figure 2a) and the ground face 24 are semicylindrical faces (see figure 2a) on the interior edge (edge of element 20 where elements 22, 23, 24 are present) wherein each of the first part (partg comprising elements 22 or 23) and the second part (part comprising element 24) of the interior edge (edge of element 20 where elements 22, 23, 24 are present) is configured to abut the tubing in arc less than 1700 (considering the number of elements present in the hole, each element will have arc less than 1700) for the purpose of determining the characteristics of the sensed feature using capacitance (column 3, line 62-column 4, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the faces of Zhang to incorporate wherein the sensor face and the ground face are semicylindrical faces on the interior edge wherein each of the first part and the second part of the interior edge is configured to abut the tubing in arc less than 1700 as taught by Tolsa for the purpose of determining the characteristics of the sensed feature using capacitance (column 3, line 62-column 4, line 2).
Regarding claim 20, Zhang discloses wherein the passage (opening between elements 42a, 42b for the tubing 20) is a notch (see figure 2 where element 28 has cut out/opening that allows tubing to slide in sideways) extending from an exterior edge (outer edge of element 28 i.e. edge not touching element 20 when inserted) and wherein the interior edge (interior edge of elements 42a, 42b) is connected to the exterior edge (outer edge of element 28).
Regarding claim 21, Zhang discloses wherein the interior edge (interior edges of elements 42a, 42b) comprises three interior sub-edges (see “E1”, “E2” and “E3” in figure 3 below) configured to at least partly abut the tubing 20, the three interior sub-edges (see “E1”, “E2” and “E3” in figure 3 below) comprising a first interior sub-edge (see “E1” in figure 3 below) and a second interior sub-edge (see “E3” in figure 3 below), the second interior sub-edge (see “E3” in figure 3 below) being arranged in parallel with, and separate from, the first interior sub-edge (see “E1” in figure 3 below).
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Regarding claim 22, Zhang is silent regarding the first interior sub-edge is conductive and defines the sensor face and the second interior sub-edge is conductive and defines the ground face.
However, Shea teaches the sensor face 24b and the ground face 24a for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Zhang modified in view of Shea will result in having one of two elements 42a and 42b of Zhang to be the sensor face and other of the two elements 42a and 42b being ground face. Therefore, 42a of Zhang could be modified to have sensor face and 42b of Zhang could be modified to have ground face.
Thus, Zhang modified in view of Shea will result in having the first interior sub-edge is conductive and defines the sensor face and the second interior sub-edge is conductive and defines the ground face.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the first and second interior sub-edges of Zhang to incorporate the first interior sub-edge is conductive and defines the sensor face and the second interior sub-edge is conductive and defines the ground face as taught by Shea for the purpose of determining the capacitive characteristics of the fluid flowing through the tubing (column 2, lines 65-70).
Regarding claim 23, Zhang is silent regarding wherein the PCB is planar and has a first thickness.
However, Tolsa teaches wherein PCB 20 is planar (see fig. 2a) and has a first thickness (thickness of element 20) for the purpose of determining the characteristics of the sensed feature using capacitance (column 3, line 62-column 4, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the circuit board of Zhang to incorporate wherein the PCB is planar and has a first thickness as taught by Tolsa for the purpose of determining the characteristics of the sensed feature using capacitance (column 3, line 62-column 4, line 2).
Zhang/Tolsa does not expressly disclose the first thickness of maximum 3 mm.
There is no evidence of record that establishes that changing the first thickness would result in a difference in function of Zhang/Tolsa device. Further, a person having ordinary skill in the art, being faced with modifying the PCB of Zhang/Tolsa would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended being given the claimed range. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the first thickness “may” be within the claimed range, and offering other acceptable ranges (for e.g. 3 mm, 2 mm or 1 mm, “PCB may have a non-zero minimum thickness” on page 4, lines 15-16) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first thickness of Zhang/Tolsa to have a maximum of 3 mm as an obvious matter of design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DeVale (US 5,464,391): discloses a design of an irrigation system for a surgical site comprising capacitor sensor assembly to monitor the fluid conditions in the tube.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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