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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/13/2024 and 10/27/2025 are being considered by the examiner.
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: first pressure transducer device in claim 2, second pressure transducer device in claims 7 and 8, medium injecting device in claim 8, pressure transducing device in claims 15, 28 and 29, medium injecting device in claim 29, first myoelectricity measuring member in claims 1 and 4, second myoelectricity measuring member in claims 1 and 10, myoelectricity measuring member in claims 14, 17, 27 and 31 and monitoring module in claims 1-2, 7, 14-15, 21, 27-28 and 35.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 states: “The neuroelectrophysiological monitoring apparatus according to claim 32”; the claim states dependance on claim 32 which is canceled. Therefore, claim 33 is of improper dependent form. For examination purposes claim 32 is taken to mean claim 31. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 limitations “first pressure transducer device”, “second pressure transducer”, “medium injecting device”, “pressure transducing device”, “medium injecting device”, “first myoelectricity measuring member”, “second myoelectricity measuring member”, “myoelectricity measuring member” and “monitoring module” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. No association between the structure and the function can be found in the specification. Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claim(s) 1-2, 14-15 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seung-June (US 20200268302 A1) herein referred to as “Seung-June”.
Regarding claim 1, Seung-June teaches: A neuroelectrophysiological monitoring apparatus, comprising: a urethra testing device ([Figure 1C]; Seung-June teaches a testing device inserted into the urethra), the urethra testing device being provided with a bladder pressure measuring member ([0108]; pressure sensor (182)) and a first myoelectricity measuring member ([Figure 1B]; EMG electrode (120a), which is seen as a myoelectricity measuring member), the bladder pressure measuring member being set in a patient's bladder ([0108]; Seung-June teaches the electrode at the tip of catheter 124, which is inserted into the bladder as disclosed by figure 1C) and adapted to measure the patient's intravesical pressure ([0108]; Seung-June teaches the pressure senser within the bladder to record pressure, which is seen as intravesical), the first myoelectricity measuring member being adapted to contact an external urethra sphincter ([0045]; Seung-June teaches electrode 120a may be inserted into the urethral sphincter, which is seen as contacting the external sphincter) to measure an external urethra sphincter electromyographic activity ([0045]; “the electrode 120a may be a needle electrode inserted into the anal sphincter or an intra-urethral electrode inserted into the urethra to measure the activity of the urethral sphincter.”) a rectum testing device ([Figure 1C]; Rectal catheter (122)), the rectum testing device being provided with a rectal pressure measuring member ([Figure 1C]; Rectal balloon (122) which is configured to record pressure) and a second myoelectricity measuring member ([0044]; Seung-June teaches a electrode 120b), the rectal pressure measuring member being set in the patient's rectum ([Figure 1B]; Seung-June teaches the rectal balloon within the patients rectum) and adapted to measure the patient's intrarectal pressure ([0044]; Seung-June disclose rectal balloon (123) configure to record intr-abdominal pressure which is seen as intrarectal), the second myoelectricity measuring member being adapted to contact an external anal sphincter to measure an external anal sphincter electromyographic activity; ([0044]; Seung-June teaches electrode 120b inserted into the anal sphincter which is seen as contacting the external sphincter and configured to measure the electromyography (EMG) signal) and a monitoring module ([Figure 1B]; Computer (132)) , the monitoring module being electrically connected to the bladder pressure measuring member, the first myoelectricity measuring member, the rectal pressure measuring member, and the second myoelectricity measuring member, respectively. ([Figure 1B]; Seung-June teaches computer (132) attached to urethral catheter (124), which contains the pressure measurement member, electrode (120a) which is seen as the first myoelectricity measuring member, rectal catheter (122), which is seen as the rectal pressure measuring member, and electrode (120b), which is seen as the second myoelectricity measuring member.
Regarding claim 2, Seung-June teaches: The neuroelectrophysiological monitoring apparatus according to claim 1. Seung-June further teaches: further comprising: a first communication tube ([Figure 1C]; Seung-June teaches a communication tube as disclosed below), the first communication tube being adapted to deliver a medium ([Figure 1C]; the communication tube is attached to a container described fluid to fill bladder) , one end of the first communication tube being open and set in the patient's bladder ([Figure 1C]; The end of the tube leads to the patients bladder), opposite end of the first communication tube extending outside the patient's body ([Figure 1C]; The opposite end is outside of the patient’s body); and a first pressure transducing device ([Figure 1C]; Pressure transducer (140)), the first pressure transducing device having a first testing ([Figure 1C]; Pressure transducer (140) has a testing end which is attached to the tubing) end and a first signal output end ([Figure 1C]; Pressure transducer (140) has a output end which leads to the computer (132)) the first testing end communicating with the first communication tube ([0062]; Seung-June teaches the pressure transducer connected to the communication tube, which is seen as in communication with the communication tube) and being adapted to measure a pressure of the medium in the first communication tube ([0062]; Seung-June teaches the bladder pressure being measured by pressure transducer (140)), the first signal output end being in communicative connection to the monitoring module ([Figure 1C]; The signal output end of pressure transducer (140) attached to computer (132)), the first pressure transducing device being adapted to convert the pressure of the medium in the first communication tube to an intravesical pressure signal ([0046]; Seung-June teaches measuring intravesical pressure while attaches to catheter (122), which is seen as communication tube) and to transmit the intravesical pressure signal to the monitoring module via the first signal output end. ([0046]; Seung-June teaches inputting the measured pressure to computer 132, which is seen as converting and transmitting the pressure measurement to a output signal, received by a monitoring module)
Regarding claim 14, Seung-June teaches: A neuroelectrophysilogical monitoring apparatus. comprising: a bladder pressure measuring member ([0108]; Pressure sensor (182)), the bladder pressure measuring member being set in a patient's bladder ([0108]; ‘…pressure sensor 182 at the tip of the catheter 124…’, [Figure 1B]; wherein catheter (124) tip is located in bladder (108) and adapted to measure the patient's intravesical pressure ([0108]; Seung-June teaches the pressure senser within the bladder to record pressure, which is seen as intravesical); a myoelectricity measuring member([0045]; Seung-June teaches electrode 120a); the myoelectricity measuring member being disposed adjacent to the bladder pressure measuring member and adapted to contact an external urethra sphincter to measure an external urethra sphincter electromyographic activity ([0045]; Seung-June teaches electrode 120a may be inserted into the urethral sphincter, which is seen as contacting the external sphincter and adjacent to the pressure sensor (108)); and a monitoring module ([Figure 1B]; Computer (132) which is seen as a monitoring module), the monitoring module being connected to the bladder pressure measuring member and the myoelectricity measuring member, respectively, to monitor the patient's intravesical pressure and external urethra sphincter electromyographic activity. ([Figure 1B]; Seung-June teaches computer (132) attached to urethral catheter (124), which contains the pressure measurement member, electrode (120a) which is seen as the myoelectricity measuring member.)
Regarding claim 15, Seung-June teaches: The neuroelectrophysiological monitoring apparatus according to claim 14. Seung further teaches: wherein the bladder pressure measuring member comprises: a communication tube ([Figure 1C]; Seung-June teaches a communication tube as disclosed in Figure 1C below), the communication tube being adapted to deliver a medium ([Figure 1C]; the communication tube is attached to a container described fluid to fill bladder), one end of the communication tube being open and set in the patient's bladder ([Figure 1C]; The end of the tube leads to the patients bladder), opposite end of the communication tube extending outside the patient's body ([Figure 1C]; The opposite end is outside of the patient’s body); a pressure transducing device ([Figure 1C]; Pressure transducer (140)), the pressure transducing device having a testing end ([Figure 1C]; Pressure transducer (140) has a testing end which is attached to the tubing) and a signal output end ([Figure 1C]; Pressure transducer (140) has a output end which leads to the computer (132)), the testing end communicating with the communication tube ([0062]; Seung-June teaches the pressure transducer connected to the communication tube, which is seen as in communication with the communication tube) and being adapted to measure a pressure of the medium in the communication tube ([0062]; Seung-June teaches the bladder pressure being measured by pressure transducer (140)), the signal output end being connected to the monitoring module ([Figure 1C]; The signal output end of pressure transducer (140) attached to computer (132)), the first pressure transducing device being adapted to convert the pressure of the medium in the first communication tube to an intravesical pressure signal ([0046]; Seung-June teaches measuring intravesical pressure while attaches to catheter (122), which is seen as communication tube) and to transmit the intravesical pressure signal to the monitoring module via the first signal output end. ([0046]; Seung-June teaches inputting the measured pressure to computer 132, which is seen as converting and transmitting the pressure measurement to a output signal, received by a monitoring module)
Regarding claim 27, Seung-June teaches: A neuroelectrophysiological monitoring apparatus, comprising: a rectal pressure measuring member ([Figure 1C]; Rectal balloon (122) which is configured to record pressure), the rectal pressure measuring member being set in a patient's rectum ([Figure 1B]; Seung-June teaches the rectal balloon within the patients rectum) and adapted to measure the patient's intrarectal pressure ([0044]; Seung-June disclose rectal balloon (123) configure to record intra-abdominal pressure which is seen as intrarectal); a myoelectricity measuring member ([0044]; Seung-June teaches a electrode 120b), the myoelectricity measuring member being disposed adjacent to the rectal pressure measuring member ([Figure 1B]; Imran teaches electrode 120b adjacent to the rectal balloon (123)) and adapted to contact an external anal sphincter to measure an external anal sphincter electromyographic activity ([0044]; Seung-June teaches electrode 120b inserted into the anal sphincter which is seen as contacting the external sphincter and configured to measure the electromyography (EMG) signal ); and a monitoring module ([Figure 1B]; Computer (132)), the monitoring module being connected to the rectal pressure measuring member and the myoelectricity measuring member, respectively, to monitor the patient's intrarectal pressure and external anal sphincter electromyographic activity. ([Figure 1B]; Seung-June teaches computer (132) attached to rectal balloon (123), which is seen as the rectal pressure measuring member, and electrode (120b), which is seen as the second myoelectricity measuring member. ([0044]; Seung-June teaches a rectal balloon (123) configure to record intra-abdominal pressure which is seen as intrarectal)
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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) 4, 6, 17-18 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June in view of Imran (US 20170231547 A1) herein referred to as “Imran”.
Regarding claim 4, Seung-June discloses: The neuroelectrophysiological monitoring apparatus according to claim 2. Seung-June does not explicitly discloses: wherein the first myoelectricity measuring member is disposed at an outer periphery of the first communication tube, wherein the first myoelectricity measuring member is formed of a plurality of first electromyography electrodes, the plurality of first electromyography electrodes being arranged at intervals in an extending direction of the first communication tube or in a circumferential direction of the first communication tube.
However, Imran discloses: wherein the first myoelectricity measuring member is disposed at an outer periphery of the first communication tube ([Figure 2]; Imran discloses electrodes (228) and (230) on the periphery of communication tube (202)), wherein the first myoelectricity measuring member is formed of a plurality of first electromyography electrodes ([Figure 2]; Electrodes 228 and 230), the plurality of first electromyography electrodes being arranged at intervals in an extending direction of the first communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202)) or in a circumferential direction of the first communication tube.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the electrodes as discloses by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 6, Seung-June discloses: The neuroelectrophysiological monitoring apparatus according to claim 2. Seung-June does not explicitly disclose: further comprising: a first communication tube anchoring device, the first communication tube anchoring device being disposed at one end of the first communication tube, the first communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder, an expandable cavity being formed inside the first communication tube anchoring device, the expandable cavity communicating with a syringe connection tube so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device.
However, Imran discloses: further comprising: a first communication tube anchoring device ([Figure 2]; Ballon (220)), the first communication tube anchoring device being disposed at one end of the first communication tube ([Figure 2]; Ballon (220) is located at the end of tube (202), the first communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder ([0016]; Imran discloses the balloon being pulled against the bladder neck which is seen as tensioning), an expandable cavity being formed inside the first communication tube anchoring device ([Figure 2]; Imran discloses a deflated anchoring device (220), [Figure 3]; Imran discloses anchoring device (220) expanded and therefore, having an expandable cavity), the expandable cavity communicating with a syringe connection tube so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device ([0035]; “The balloon 220 will be inflated by a conventional inflation source 222 of the type normally used with Foley catheters”, [Figure 2]; Imran discloses (222) as an inlet tube that provides medium to the balloon).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the anchoring device as disclosed by Imran. The motivation being to stabilize the catheter ([0035]).
Regarding claim 17, Seung-June discloses: The neuroelectrophysiological monitoring apparatus according to claim 15. Seung-June does not explicitly disclose: wherein the myoelectricity measuring member is disposed at an outer periphery of the communication tube, wherein the myoelectricity measuring member comprises: a plurality of electromyography electrodes, the plurality of electromyography electrodes being arranged at intervals at an outer periphery of the communication tube.
However, Imran discloses: wherein the myoelectricity measuring member is disposed at an outer periphery of the communication tube ([Figure 2]; Imran discloses electrodes (228) and (230) on the periphery of communication tube (202)), wherein the myoelectricity measuring member comprises: a plurality of first electromyography electrodes ([Figure 2]; Electrodes 228 and 230), the plurality of electromyography electrodes being arranged at intervals in an extending direction of the communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the electrodes as discloses by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 18, Seung-June in view of Imran discloses: The neuroelectrophysiological monitoring apparatus according to claim 17. Imran further discloses: wherein each of the electromyography electrodes is configured to have a stripped shape ([Figure 2]; Imran discloses electrodes (228) and (230) having a stripped shape), an extending direction of the electromyography electrodes being consistent with an extending direction of the communication tube ([Figure 2]; Electrodes (228) and (230) are extending in the direction of rube (202)), the plurality of electromyography electrodes being arranged at intervals at the outer periphery of the communication ([Figure 2]; Imran discloses electrodes (228) and (230) arranged in interval at the outer periphery of tube (202)) wherein each of the electromyography electrodes is configured to have a ring shape and disposed surrounding the communication tube ([Figure 2]; Imran discloses electrode (228) and (230) having a ring shape and surrounding the tube (202)), the plurality of electromyography electrodes being arranged at intervals in the extending direction of the communication tube. ([Figure 2]; electrodes (228) and (230) are arranged at intervals in the direction of tube (202)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the electrodes as discloses by Imran. The motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 21, Seung-June in view of Imran disclose: The neuroelectrophysiological monitoring apparatus according to claim 19. Imran further discloses: further comprising: an electromyography electrode connecting harness ([0035]; Imran discloses electrodes (228) and (230) being connected to wires (238), which is seen as an electromyography electrode connecting harness), the electromyography electrode connecting harness being at least partially set in the communication tube ([0035]; Imran discloses wires (238) passing through the catheter body, which is seen as being at least partially set in a communication tube), one end of the electromyography electrode connecting harness being connected to the plurality of electromyography electrodes ([0035]), opposite end of the electromyography electrode connecting harness being connected to the monitoring module. ([0035]; Imran discloses wires (238) connecting to controller (216), which is seen as a monitoting module)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran with the electrode harness as further disclosed by Imran the motivation being to connect the electrodes to a control module ([0035]).
Regarding claim 22, Seung-June discloses: The neuroelectrophysiological monitoring apparatus according to claim 15. Seung-June does not explicitly disclose: further comprising: a communication tube anchoring device, the communication tube anchoring device being set at the one end of the communication tube, the communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder, wherein an expandable cavity is formed inside the communication tube anchoring device, the expandable cavity communicating with a syringe connection tube, so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device.
However, Imran discloses: further comprising: a communication tube anchoring device ([Figure 2]; Ballon (220)), the communication tube anchoring device being set at the one end of the communication tube ([Figure 2]; Ballon (220) is located at the end of tube (202), the communication tube anchoring device being selectively deformed to be tensioned in the patient's bladder ([0016]; Imran discloses the balloon being pulled against the bladder neck which is seen as tensioning), wherein an expandable cavity is formed inside the communication tube anchoring device ([Figure 2]; Imran discloses a deflated anchoring device (220), [Figure 3]; Imran discloses anchoring device (220) expanded and therefore, having an expandable cavity), the expandable cavity communicating with a syringe connection tube, so that the medium is injected into the expandable cavity to control deformation of the communication tube anchoring device. ([0035]; “The balloon 220 will be inflated by a conventional inflation source 222 of the type normally used with Foley catheters”, [Figure 2]; Imran discloses (222) as an inlet tube that provides medium to the balloon).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the anchoring device as disclosed by Imran the motivation being to stabilize the catheter ([0035]).
Claim(s) 7-8 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June in view of Hvid et al. (WO 2020207547 A1) herein referred to as “Hvid”.
Regarding claim 7, Seung-June discloses: The neuroelectrophysiological monitoring apparatus according to claim 2. Seung-June does not explicitly disclose: wherein the rectal pressure measuring member comprises: a second communication tube, the second communication tube being adapted to deliver the medium, one end of the second communication tube being set in the patient's rectum, opposite end of the second communication tube extending outside the patient's body; an intrarectal expandable balloon, the intrarectal expandable balloon being disposed at one end of the second communication tube and communicating with the second communication tube, an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum; and a second pressure transducing device, the second pressure transducing device having a second testing end and a second signal output end, the second testing end communicating with the second communication tube and being adapted to measure a pressure of the medium in the second communication tube, the second signal output end being in communicative connection to the monitoring module, the second pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module via the second signal output end.
However, Hvid discloses: wherein the rectal pressure measuring member comprises: a second communication tube ([Figure 1C]; Hvid discloses communication tube (115)), the second communication tube being adapted to deliver the medium ([(61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as being adapted to deliver medium), one end of the second communication tube being set in the patient's rectum ([Figure 1C]; Hvid discloses one end of tube (115) within the patients rectum (3)), opposite end of the second communication tube extending outside the patient's body ([Figure 1C]; Hvid discloses an opposite end outside of the patients rectum (3)); an intrarectal expandable balloon ([Figure 1C]; Hvid discloses expandable balloon (111)), the intrarectal expandable balloon being disposed at one end of the second communication tube and communicating with the second communication tube ([61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as balloon (111) being in communication with a communication tube (115)), an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum ([Figure 1C]; Hvid discloses balloon (111) against rectum walls (4)); and a second pressure transducing device ([Figure 4]; Pressure sensor (414)), the second pressure transducing device having a second testing ([Figure 4]; Hvid discloses a testing end attached to the tube) end and a second signal output end ([Figure 4]; Hvid discloses a signal output end (404’)), the second testing end communicating with the second communication tube ([Figure 4, which is an illustration of a bowel irrigation system that includes the catheter as disclosed in Figure 1C.]; Hvid discloses pressure sensor in communication with 402, [(68)]; Hvid discloses “The tubing 402 can comprise a first and a second lumen, such that a separate fluid communication can be established between the container 401 and the balloon 411 through the first lumen”) and being adapted to measure a pressure of the medium in the second communication tube ([(68)]; Hvid discloses pressure sensor (414) in fluid connection with the ballon (411) and therefore must read pressure from tube (402)), the second signal output end being in communicative connection to the monitoring module ([Figure 4]; output end (404’) in communication with control unit (404), which is seen a monitoring module), the second pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and transmit the intrarectal pressure signal to the monitoring module via the second signal output end. ([(68)]; Hvid discloses pressure sensor (414) in connection with control unit (404) and relaying pressure information via coupling (404’))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the fluid medium tubbing and pressure sensor as disclosed by Hvid. The motivation being to inflate the rectal balloon ([(62)]) and monitor pressure within the balloon ([(68)]) respectively.
Regarding claim 8, Seung-June in view of Hvid disclose: The neuroelectrophysiological monitoring apparatus according to claim 7. Hvid further discloses: wherein the opposite end of the second communication tube is adaptable to be connected to the medium injecting device ([(68)]; Hvid discloses lumens in tube (402) which is connected to catheter (410), which contains channel (115), which is seen as the second communication tube. Further Hvid discloses lumens in fluid communication with fluid pump (403), which is seen as a medium injecting device), the medium injecting device selectively injecting the medium into the second communication tube ([(68)]; “Thereby, liquid held in the container 401 can be pumped selectably into the balloon 410, and through eyelets provided in the proximal end 413 of the catheter 410”). wherein the neuroelectrophysiological monitoring apparatus further comprising: a three- way tube ([Figure 4]; Hvid discloses a three-way tube as shown by the black square below), the three-way tube having a first interface, a second interface, and a third interface which selectively communicate with each other ([Figure 4]; Hvid discloses three interfaces as disclosed below with arrows , ([(68)]; Hvid discloses the interfaces in fluid communication with each other which is seen as selectively communicating with each other), the first interface being connected to the opposite end of the second communication tube ([Figure 4]; Hvid discloses a firest interface in communication with tube (402)), the second interface being connected to the second testing end of the second pressure transducing device ([Figure 4]; Hvid discloses a second interface in communication with testing end of pressure sensor (414)), the third interface being connected to the medium iniecting device. ([Figure 4]; Hvid discloses the third interface in communication with container (403), [(68)]; “a pump 403 (not shown, but is preferably incorporated in the container, e.g. in the bottom)” wherein the pump (403) is seen as medium injecting device)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the three way tube as further disclosed by Hvid. The motivation being to have pressure sensor, pump and communication tube in fluid communication ([(68)].
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Regarding claim 28, Seung-June discloses: The neuroelectromyographic monitoring apparatus according to claim 27. Seung-June does not explicitly disclose: wherein the rectal pressure measuring member comprises: a communication tube, the communication tube being adapted to deliver a medium, one end of the communication tube being set in the patient's rectum, opposite end of the communication tube extending outside the patient's body; an intrarectal expandable balloon, the intrarectal expandable balloon being disposed at the one end of the communication tube and communicating with the communication tube, an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum; and a pressure transducing device, the pressure transducing device having a testing end and a signal output end, the testing end communicating with the opposite end of the communication tube and being adapted to measure a pressure of the medium in the communication tube, the signal output end being in communicative connection to the monitoring module, the pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and to transmit the intrarectal pressure signal to the monitoring module via the signal output end.
However, Hvid discloses: wherein the rectal pressure measuring member comprises: a communication tube ([Figure 1C]; Hvid discloses communication tube (115)), the communication tube being adapted to deliver a medium ([(61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as being adapted to deliver medium), one end of the communication tube being set in the patient's rectum ([Figure 1C]; Hvid discloses one end of tube (115) within the patients rectum (3)), opposite end of the communication tube extending outside the patient's body ([Figure 1C]; Hvid discloses an opposite end outside of the patients rectum (3)); an intrarectal expandable balloon ([Figure 1C]; Hvid discloses expandable balloon (111)), the intrarectal expandable balloon being disposed at the one end of the communication tube and communicating with the communication tube ([61)]; “The inflation channel 115 is in fluid communication with a container holding the liquid used for inflating the balloon 111” which is seen as balloon (111) being in communication with a communication tube (115)), an outer peripheral wall of the intrarectal expandable balloon abutting against an inside lining of the patient's rectum ([Figure 1C]; Hvid discloses balloon (111) against rectum walls (4)); and a pressure transducing device ([Figure 4]; Pressure sensor (414)), the pressure transducing device having a testing end ([Figure 4]; Hvid discloses a testing end attached to the tube) and a signal output end ([Figure 4]; Hvid discloses a signal output end (404’)), the testing end communicating with the opposite end of the communication tube ([Figure 4, which is an illustration of a bowel irrigation system that includes the catheter as disclosed in Figure 1C.]; Hvid discloses pressure sensor in communication with 402, [(68)]; Hvid discloses “The tubing 402 can comprise a first and a second lumen, such that a separate fluid communication can be established between the container 401 and the balloon 411 through the first lumen”) and being adapted to measure a pressure of the medium in the communication tube ([(68)]; Hvid discloses pressure sensor (414) in fluid connection with the ballon (411) and therefore must read pressure from tube (402)), the signal output end being in communicative connection to the monitoring module ([Figure 4]; output end (404’) in communication with control unit (404), which is seen a monitoring module), the pressure transducing device being adapted to convert the pressure of the medium to an intrarectal pressure signal and to transmit the intrarectal pressure signal to the monitoring module via the signal output end. ([(68)]; Hvid discloses pressure sensor (414) in connection with control unit (404) and relaying pressure information via coupling (404’))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June with the fluid medium tubbing and pressure sensor as disclosed by Hvid the motivation being to inflate the rectal balloon ([(62)]) and monitor pressure within the balloon ([(68)]) respectively.
Regading claim 29, Seung-June in view of Hvid disclose: The neuroelectrophysiological monitoring apparatus according to claim 28. Hvid further discloses: wherein the opposite end of the communication tube is adaptable to be connected to a medium injecting device ([(68)]; Hvid discloses lumens in tube (402) which is connected to catheter (410), which contains channel (115), which is seen as the second communication tube. Further Hvid discloses lumens in fluid communication with fluid pump (403), which is seen as a medium injecting device), the medium injecting device selectively injecting the medium into the communication tube ([(68)]; “Thereby, liquid held in the container 401 can be pumped selectably into the balloon 410, and through eyelets provided in the proximal end 413 of the catheter 410”). wherein the neuroelectrophysiological monitoring apparatus further comprising: a three-way tube ([Figure 4]; Hvid discloses a three-way tube as shown by the black square in Figure 4 above), the three-way tube having a first interface, a second interface, and a third interface which selectively communicate with each other ([Figure 4]; Hvid discloses three interfaces as disclosed above in Figure 4 with arrows , ([(68)]; Hvid discloses the interfaces in fluid communication with each other which is seen as selectively communicating with each other), the first interface being connected to the opposite end of the communication tube ([Figure 4]; Hvid discloses a first interface in communication with tube (402)), the second interface being connected to the testing end of the pressure transducing device ([Figure 4]; Hvid discloses a second interface in communication with testing end of pressure sensor (414)), the third interface being connected to the medium injecting device. ([Figure 4]; Hvid discloses the third interface in communication with container (403), [(68)]; “a pump 403 (not shown, but is preferably incorporated in the container, e.g. in the bottom)” wherein the pump (403) is seen as medium injecting device)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the three-way tube as further disclosed by Hvid the motivation being to have pressure sensor, pump and communication tube in fluid communication ([(68)].
Claim(s) 10, 31, 33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June in view of Hvid further in view of Imran.
Regarding claim 10 Seung-June in view of Hvid disclose: The neuroelectrophysiological monitoring apparatus according to claim 8. Seung-June in view of Hvid do not explicitly disclose: wherein the second myoelectricity measuring member is disposed at an outer periphery of the second communication tube, wherein the second myoelectricity measuring member is formed of a plurality of second electromyography electrodes, the plurality of second electromyography electrodes being arranged at intervals in an extending direction of the second communication tube or in a circumferential direction of the first communication tube.
However, Imran discloses: wherein the second myoelectricity measuring member is disposed at an outer periphery of the second communication tube ([Figure 2]; Imran discloses electrodes (228) and (230) on the periphery of communication tube (202)), wherein the second myoelectricity measuring member is formed of a plurality of second electromyography electrodes ([Figure 2]; Electrodes 228 and 230), the plurality of second electromyography electrodes being arranged at intervals in an extending direction of the first communication tube ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202)) or in a circumferential direction of the first communication tube.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the electrodes as discloses by Imran the motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 31, Seung-June in view of Hvid disclose: The neuroelectrophysiological monitoring apparatus according to claim 28. Seung-June in view Of Hvid do not explicitly disclose: wherein the myoelectricity measuring member is disposed at an outer periphery of the communication tube, wherein the myoelectricity measuring member comprises: a plurality of electromyographic electrodes, the plurality of electromyographic electrodes being arranged at intervals at the outer periphery of the communication tube.
However, Imran discloses: wherein the myoelectricity measuring member is disposed at an outer periphery of the communication tube tube ([Figure 2]; Imran discloses electrodes (228) and (230) on the periphery of communication tube (202)), wherein the myoelectricity measuring member comprises: a plurality of electromyographic electrodes ([Figure 2]; Electrodes 228 and 230), the plurality of electromyographic electrodes being arranged at intervals at the outer periphery of the communication tube. ([Figure 2]; Electrodes (228) and (230) are arranged at intervals from each other extending in the direction of the communication tube (202))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the electrodes as discloses by Imran the motivation being to provide stimulation to the pudendal nerve ([0015])
Regarding claim 33, Seung-June in view of Hvid further in view of The neuroelectrophysiological monitoring apparatus according to claim 32, Seung-June in view of Hvid do not explicitly disclose: wherein each of the electromyographic electrodes is configured to have a stripped shape, an extending direction of the electromyographic electrodes being consistent with an extending direction of the communication tube, the plurality of electromyographic electrodes being arranged at intervals at the outer periphery of the communication or, wherein each of the electromyographic electrodes is configured to have a ring shape and disposed surrounding the communication tube, the plurality of electromyographic electrodes being arranged at intervals in the extending direction of the communication tube.
However, Iman discloses: wherein each of the electromyography electrodes is configured to have a stripped shape ([Figure 2]; Imran discloses electrodes (228) and (230) having a stripped shape), an extending direction of the electromyography electrodes being consistent with an extending direction of the communication tube ([Figure 2]; Electrodes (228) and (230) are extending in the direction of rube (202)), the plurality of electromyography electrodes being arranged at intervals at the outer periphery of the communication ([Figure 2]; Imran discloses electrodes (228) and (230) arranged in interval at the outer periphery of tube (202)) or wherein each of the electromyography electrodes is configured to have a ring shape and disposed surrounding the communication tube ([Figure 2]; Imran discloses electrode (228) and (230) having a ring shape and surrounding the tube (202)), the plurality of electromyography electrodes being arranged at intervals in the extending direction of the communication tube. ([Figure 2]; electrodes (228) and (230) are arranged at intervals in the direction of tube (202)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the electrodes as discloses by Imran the motivation being to provide stimulation to the pudendal nerve ([0015]).
Regarding claim 35, Seung-June in view of Hvid further in view of Imran disclose: The neuroelectrophysiological monitoring apparatus according to claim 33. Imran further discloses: further comprising: an electromyography electrode connecting harness ([0035]; Imran discloses electrodes (228) and (230) being connected to wires (238), which is seen as an electromyography electrode connecting harness), the electromyography electrode connecting harness being at least partially set in the communication tube ([0035]; Imran discloses wires (238) passing through the catheter body, which is seen as being at least partially set in a communication tube), one end of the electromyography electrode connecting harness being connected to the plurality of electromyography electrodes ([0035]), opposite end of the electromyography electrode connecting harness being connected to the monitoring module. ([0035]; Imran discloses wires (238) connecting to controller (216), which is seen as a monitoting module)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Imran with the electrode harness as further disclosed by Imran the motivation being to connect the electrodes to a control module ([0035]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seung-June in view of Hvid further in view of Pinchuk et al. (US 20140012235 A1) herein referred to as “Pinchuk”.
Regarding claim 36, Seung-June in view of Hvid disclose: The neuroelectrophysiological monitoring apparatus according to claim 28. Seung-June in view of Hvid do not explicitly disclose: wherein a plurality of scale markers arranged at intervals in the extending direction of the communication tube are provided on an outer peripheral wall of the communication tube.
However, Pinchuk discloses: wherein a plurality of scale markers ([0155]; Markers (1030) and (1032) arranged at intervals in the extending direction of the communication tube are provided on an outer peripheral wall of the communication tube. ([Figure 9]; Pinchunk discloses markers (1030) and (1032) arranged at intervals and provided on an outer peripheral wall of catheter shaft (1020))
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the neuroelectrophysiological monitoring apparatus as disclosed by Seung-June in view of Hvid with the scale markers as disclosed by Pinchunk the motivation being to indicate average length of female and male urethras ([0155])
Conclusion
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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