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 statement (IDS) submitted on 11/20/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is greater than 150 words in length and also refers purported merits or speculative applications of the invention (“The esophagus pH-myoelectricity combined electrode catheter can easily and accurately position pH electrodes to stomach and esophagus to reduce discomfort. With this technique gastroesophageal reflux and diaphragm function could be assessed and the potential cause of gastroesophageal reflux could be determined.”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claims 1-7 are rejected because they comprise multiple sentences and antecedent basis issues, which render the claims indefinite. Per MPEP 608.1(m), each claim must be the object of a single sentence and must end with a period. The current claims contain multiple periods within the body of the claim, which renders the scope of the claim unclear
Furthermore, Claims 1-7 are riddled with antecedent basis issues, elements are preemptively introduced using “the” (instead of “a”) and relations between parts are ambiguous rather than explained/defined by the claim. Without clear antecedent basis, the scope of the claims is very unclear because it is unknown if these terms refer to elements recited or new, distinct elements. Due to the great number of antecedent issues, the Examiner has reproduced the claims below, has bolded the indefinite limitations, and in parenthesis has provided how the indefinite limitations are being interpreted.
Claim 1: An esophagus PH-myoelectricity combined electrode catheter, comprising a catheter body, two wires inside the catheter connecting to PH sensors (unclear if “the catheter” is the same catheter as “a catheter body”; unclear if the catheter connects to the pH sensors or if the two wires connect to the pH sensors; For purposes of examination the indefinite limitation has been deemed to claim the two wires are inside the catheter body, where the two wires each individually connect to the pH sensors),
and five wires inside the catheter connecting to electrodes for recording the diaphragm EMG (unclear if “the catheter: is the same as “a catheter body”; unclear if the catheter connects the pH sensors or if the five wires connect to the pH sensors; For purposes of examination the indefinite limitation has been deemed to claim the five wires are inside the catheter body, where the five wires each individually connect to the five electrodes).
PH sensors (unclear if these are the same pH sensors as previously recited in the claim; For purposes of examination the indefinite limitation has been deemed to claim the same pH sensors, i.e., “the pH sensors”) and the electrodes for diaphragm EMG (unclear because while electrodes are previously recited, they were not previously recited “for diaphragm EMG”; For purposes of examination the indefinite limitation has been deemed to claim that the previously recited electrodes are also for diaphragm EMG)
are attached on the surface of the catheter (unclear/lacking antecedent basis because a surface has not been previously claimed; For purposes of examination the indefinite limitation has been deemed to claim “a surface”).
The two PH sensors (unclear/lacking antecedent basis because the claim previously sets forth pH sensors, but doesn’t limit the claim to two sensors; For purposes of examination the indefinite limitation has been deemed to claim that there are two pH sensors)
are located at the distal end and the middle part of the catheter, respectively (unclear/lacking antecedent basis because “the distal” and “the middle part” lack proper antecedent basis; For purposes of examination the indefinite limitation has been deemed to claim “a distal” and “a middle part”).
The five electrodes for EMG recording (unclear because while electrodes are previously recited, they were not previously recited “for EMG recording”; For purposes of examination the indefinite limitation has been deemed to claim that the electrodes are capable of EMG recording)
are located between the two PH sensors while the reference electrode (unclear/lacking antecedent basis because a reference electrode has not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim “a reference electrode”) is located between
the proximal PH sensor and the proximal end of the catheter (unclear/lacking antecedent basis because a proximal pH sensor and proximal end of the catheter has not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim “a proximal pH sensor” and “a proximal end of the catheter”)
The wires inside the catheter connect to PH sensors (unclear because there are 7 wires recite, 2 to the pH sensors and 5 to the electrodes; For purposes of examination the indefinite limitation has been deemed to claim/reference the two wires inside the catheter that connect to the pH sensors)
are further connected to a PH processor connector (unclear because it is not appear what is “further connected” to a pH processor connector, the wires? The pH sensor? Some other element?; For purposes of examination the indefinite limitation has been deemed to claim where the wires are connected to a pH processor connector)
at the proximal end (unclear because it is not clear what proximal end is being references; For purposes of examination the indefinite limitation has been deemed to claim the proximal end of the catheter)
while the wires inside the catheter (unclear because there are 7 wires recite, 2 to the pH sensors and 5 to the electrodes; For purposes of examination the indefinite limitation has been deemed to claim/reference the fives wires inside the catheter that connect to the electrodes)
connect to the electrodes for recording diaphragm EMG are all separately connected to a bio-amplifier (unclear because Claim 1 recites “recording the diaphragm EMG”, “EMG recording, and “electrodes for recording diaphragm EMG” and the exact functionality of the electrodes and associated recording is not consistently recited; For purposes of examination the indefinite limitation has been deemed to claim that the electrodes are configured to/capable of diaphragm EMG measurements/recording).
Claim 2: The esophagus PH-myoelectricity combined electrode catheter of claim 1, where there are five electrodes for recording diaphragm EMG (unclear if the five electrodes are the same five electrodes as recited in Claim 1; For purposes of examination the indefinite limitation has been deemed to claim the same five electrodes)
which are 1 cm in length for each electrode (unclear because “for each electrode” sounds as if there is another element that is 1 cm in length; For purposes of examination the indefinite limitation has been deemed to claim that each electrode of the five electrodes are 1 cm in length)
and the distance between adjacent electrodes is 1 cm (unclear/lacking antecedent basis because a distance has not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim “a distance”).
The distal electrode for recording diaphragm EMG (unclear/lacking antecedent basis because a distal electrode has not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim the distal most electrode of the give electrodes for EMG recording as set forth in Claim 1)
is 5 cm away from the distal PH sensor (unclear/lacking antecedent basis because a distal pH sensor has not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim a distal-most pH sensor of the two pH sensors as recited in Claim 1),
while a space is also 5 cm (unclear because it is not known what is implied by space; For purposes of examination the indefinite limitation has been deemed to claim any length that exists within or is part of an overall distance or area)
between the proximal PH sensor and the middle electrode for recording diaphragm EMG (unclear/lacking antecedent basis because a proximal pH sensor and a middle electrode for recording diaphragm EMG have not been previously recited; For purposes of examination the indefinite limitation has been deemed to claim the proximal-most pH sensor of the two pH sensors and any of the electrodes being middle electrodes, since they are sandwiched between the two pH sensors).
Claim 3: The esophagus PH-myoelectricity combined electrode catheter of claim 2, wherein the distance between two adjacent diaphragm electromyographic signal recording electrodes is 1 cm (unclear because Claim 2 previously claims that the distance between adjacent electrodes is 1 cm and Claim 3 states that the distance between two adjacent diaphragm electromyographic signal recording electrodes is 1 cm, are these different electrodes?; For purposes of examination the indefinite limitation has been deemed to claim that there are a set of 5 electrodes, where each electrode is 1 cm away from the electrodes on either side of the electrode).
Claim 4: The esophagus PH-myoelectricity combined electrode catheter of claim 2, wherein the five electrodes for recording diaphragm EMG (unclear because as previously recited in Claim 1, the five electrodes are for EMG recording, but as recited in Claim 4, they are for recording diaphragm EMG, so it is unknown if these are the same electrodes; For purposes of examination the indefinite limitation has been deemed to claim the same EMG electrodes) form three pairs of electrodes with the exact same distance between electrodes within a pair (generally it is unclear what constitutes a pair, how 5 electrodes only form three pairs, and when is meant by having an “exact distance” by these ambiguous pairs; For purposes of examination the indefinite limitation has been deemed to claim that there are 5 electrodes, each equal distance from one another, which would inherently include pairs of electrodes). The middle electrode is the common electrode for upper and lower pairs (unclear/lacking antecedent basis because the limitation “the common electrode” has not been previously recited in the claim, nor have upper and lower pairs been previously recited, nor is there a frame of reference for what is an upper and lower pair; For purposes of examination the indefinite limitation has been deemed to claim any electrode can be common, and the upper pairs are proximal on the catheter and lower pairs are distal on the catheter).
Claim 5: The esophagus PH-myoelectricity combined electrode catheter of claim 1, wherein the electrodes for recording diaphragm EMG (unclear because Claim 1 recites “recording the diaphragm EMG”, “EMG recording, and “electrodes for recording diaphragm EMG” and the exact functionality of the electrodes and associated recording is not consistently recited; For purposes of examination the indefinite limitation has been deemed to claim that the electrodes are configured to/capable of diaphragm EMG measurements/recording) and the reference electrode all are 1 cm in length.
Claim 7: The esophagus PH-myoelectricity combined electrode catheter of claim 1, where the distal end of the catheter is sealed with a cap, the proximal end of the catheter has a bifurcated head which is further extended to PH processor connector for measurement of PH and extended to bio-amplifier connector (unclear because it is grammatically confusing a bifurcated head would extend to a pH processor, when such head would have at least two parts, and it is further unclear what is being extended to a bio-amplifier connector, the head? The connector? The proximal end?; For purposes of examination the indefinite limitation has been deemed to claim that in some manner, the catheter extends to the pH processor, and then ethe pH processor extends to the bio-amplifier connector.
Claim Rejections - 35 USC § 103
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20110112429 A1 to Stuebe et al. (hereinafter, Stuebe) in view of Comprehensive analysis of acidic pharyngeal reflux before and after proton pump inhibitor treatment in patients with suspected laryngopharyngeal reflux to Duricek.
Regarding Claims 1 and 7, discloses an esophagus pH-myoelectricity combined electrode catheter, comprising inter alia:
a catheter body (para. [0028] “…a long, slender catheter or probe 102 positioned in the esophagus E…”),
a wire inside the catheter connecting to a pH sensor (para. [0036] “…one or more pH sensors on the probe 102 for sensing the pH level…”) (para. [0031] “The pH sensor 130 is connected electrically to a pH sensor circuit 137 in the data collection device 114, as illustrated schematically by phantom line 149…”), and
five wires inside the catheter connecting to electrodes for recording the diaphragm EMG (para. [0030] “The electrical connections connect the electrodes 121, 122, 123, 124, 125, 126, 127, 128…by phantom lines 141, 142, 143, 144, 145, 146, 147, 148…provided by electric wires (not shown) running through the probe 102)”;
pH sensors and the electrodes for diaphragm EMG are attached on the surface of the catheter (para. [0028] “… electrodes 121, 122, 123, 124, 125, 126, 127, 128, dispersed in spaced-apart relation to each other along the length of the catheter 102…”) (para. [0031] “…position the probe 102 in the patient's P esophagus E so that the pH sensor 130 and electrodes 121, 122, 123, 124, 125, 126, 127, 128 are located at desired spatial relationships…”) (all sensors can be seen attached on the surface of the catheter in FIG. 2);
the pH sensor is located at the middle part of the catheter (FIG. 2 discloses pH sensor 130 located in a “middle part” of the catheter between electrodes 126 and 127);
a reference electrode (para. [0031] “…an antimony billet and a reference, are well-known in the art and do not have to be described here for an understanding of this invention.”);
the wires inside the catheter connect to pH sensors are further connected to a pH processor connector at the proximal end (para. [0031] “The pH sensor 130 is connected electrically to a pH sensor circuit 137 in the data collection device 114, as illustrated schematically by phantom line 149, to provide a seventh data channel CH7 with pH data. Such pH data is also logged into and recorded by the data collection device 114 on a real time basis and sent simultaneously or later to the data analysis device 116.”) while the wires inside the catheter connect to the electrodes for recording diaphragm EMG are all separately connected to a bio-amplifier (para. [0029] “The electrodes 121, 122, 123, 124, 125, 126, 127, 128 are connected electrically to electric circuits or components, e.g., circuits 131, 132, 133, 134, 135, 136, which detect and measure or quantify impedance (opposition to flow of electric current) between adjacent ones of the electrodes 121, 122, 123, 124, 125, 126, 127, 128.”) (para. [0030] “…the impedance measurements on the six channels CH1, CH2, CH3, CH4, CH5, CH6 from the respective circuits 131, 132, 133, 134, 135, 136 into data that can be logged into and recorded by data collection device 114 on a real time basis and delivered either simultaneously or later to a data analysis device 116.”); and
(Claim 7) wherein the distal end of the catheter is sealed with a cap (respective channels and wires within body are sealed by the rounded, closed cap at the end of catheter, as best seen at the distal end of the catheter in FIG. 2), the proximal end of the catheter has a bifurcated head (data collection device, which has multiple channels, hence “bifurcated”) which is further extended to pH processor connector (Data Analysis Device, Fig. 1) for measurement of pH and extended to bio-amplifier connector (para. [0031] “Such pH data is also logged into and recorded by the data collection device 114 on a real time basis and sent simultaneously or later to the data analysis device 116.”).
Stuebe discloses the claimed invention as set forth and cited above except for expressly disclosing:
(a) where there are two wires inside the catheter connecting to two pH sensors (Stuebe discloses two pH sensors at para. [0036], but only addresses the wiring with respect to a single pH sensor at para. [0031]);
(b) where two pH sensors are located at the distal end and the middle part of the catheter, where the five electrodes for EMG recording are located between the two pH sensors (Stuebe discloses two pH sensors at para. [0036], but only addresses the placement of a single pH sensor as being on the middle part of the catheter at paragraph [0032]) (Stuebe discloses 5 electrodes and 2 pH sensors, but does not expressly disclose the embodiment of five electrodes disposed between pH sensors, however, Stuebe contemplates that other sensor configurations, spacings and pairings could be used with the invention at para. [0030]);
(c) where the reference electrode is located between the proximal pH sensor and the proximal end of the catheter (Stuebe discloses that reference electrodes are well-known in the art at paragraph [0031], but does not disclose where the reference electrode is placed, however, Stuebe contemplates that other sensor configurations, spacings and pairings could be used with the invention at para. [0030]).
However, regarding (a), one having an ordinary skill in the art at the time the invention was filed would have found it obvious to duplicate the same proven pH sensor wiring of Stuebe for the additional second pH sensor because the second pH sensor is the same type of electrochemical sensing element and therefore needs the same basic electrical connection to the pH circuitry using the already-disclosed wiring scheme. The second disclosed pH sensor of Stuebe on the same catheter predictably requires adding a corresponding wiring scheme which is a standard replication modification with reasonable expectation of success. Such modification of the second pH sensor of Stuebe with identical wiring of the first pH sensor of Stuebe is simple duplication of essential working parts.
Furthermore, regarding (b) and (c), Duricek teaches a catheter with electrodes and pH sensors for pH and impedance monitoring within the esophagus (Patients and methods, Page 4 “Simultaneous pharyngeal and esophageal 24-hour pH/impedance monitoring was performed with pH/impedance catheters VersaFlex with two pH sensors and eight impedance electrodes (given imaging).”). Duricek teaches (a) a first pH sensor located at the distal end and a second pH sensor located at the middle part of the catheter and a plurality of electrodes for EMG electrodes located between the two pH sensors (Patients and methods, Page 4, “In catheters with pH sensors distance 15 cm, impedance electrodes were…1, 3 and 5 cm above the distal pH sensor and 1 and 3 cm below…the proximal pH sensor.”) and a reference electrode located between the a proximal pH sensor and the proximal end of the catheter (Patients and methods, Page 4, “In catheters with pH sensors distance 15 cm, impedance electrodes were…1 cm above the proximal pH sensor.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the arrangement of the two pH sensors, fives electrodes and reference electrode of Stuebe with the pH sensors arrangement sandwiching the five electrodes and proximal reference electrode arrangement of Duricek because Stuebe contemplates that other sensor configurations, spacings and pairings could be used with the invention at para. [0030] and Duricek teaches that their disclosed arrangement of multiple electrodes sandwiched between pH sensors is the best way to detect LPR is using simultaneous pharyngeal and distal esophageal pH and impedance monitoring (Patients and methods, Page 4 “In our view, simultaneous pharyngeal and distal esophageal pH/impedance monitoring has the best potential to detect LPR as it allows tracing the progress of a reflux episode from the distal esophagus toward the pharynx. Simultaneous pharyngeal and esophageal 24-hour pH/impedance monitoring was performed with pH/impedance catheters VersaFlex with two pH sensors and eight impedance electrodes (given imaging).”).
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stuebe in view Duricek and further in view of Diaphragm electromyography using an oesophageal catheter: current concepts to Luo et al. (hereinafter, Luo).
The combination of Stuebe in view Duricek teach the esophagus pH-myoelectricity combined electrode catheter of claim 1, including the five electrodes sandwiched between two respective pH sensors and the reference sensor proximal of the proximal pH sensor.
It is noted that Duricek further teaches where a distal electrode for recording diaphragm EMG is 5 cm away from a distal pH sensor because any of the electrodes that are distal of the proximal pH sensor are being interpreted as “distal electrodes” as they are “distal” the proximal pH sensor and Duricek teaches at least one of these electrodes are 5 cm away from the distal pH sensor (Patients and methods, Page 4, “…impedance electrodes were…5 cm above the distal pH sensor…”).
It is noted that Duricek further teaches where “a space” between a middle electrode and the proximal pH sensor is 5 cm because all of the electrodes are being interpreted as “middle” electrodes, because they are all sandwiched between the proximal and distal pH sensors, and “a space” is being interpreted as any distance that exists between the proximal pH sensor and any of the electrodes. Therefore, the electrodes 1, 3 and 5 cm above the distal pH sensor, while each having a distance greater than 5 cm to the proximal pH sensor, all at least have “a space” that is 5 cm, because “a space” that is 5 cm exists within that distance.
The motivational reasoning for such combination is the same as set forth above with respect to Claim 1, as seen in para. [0030] of Stuebe and Patients and methods, Page 4 of Duricek.
Stuebe in view Duricek do not expressly disclose where the EMG electrodes each are 1 cm in length and are each adjacent electrodes are spaced 1 cm apart and where the reference electrodes is 1 cm in length. However, Luo teaches an esophageal catheter with electrodes for taking EMG recordings (Abstract). Lue teaches where each electrode is 1 cm in length (FIG. 4 description “Each electrode is 1 cm in length…”) and where the electrodes adjacent to one another are spaced a 1 cm distance (FIG. 4 description “…1 cm gap between electrodes.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the length and adjacent spacing of the electrodes of Stuebe in view Duricek to each be 1 cm and the also make the reference electrode to be 1 cm in length as set forth in Luo, because Stuebe contemplates that other sensor configurations, spacings and pairings could be used with the invention at para. [0030] and Luo teaches that such size and spacing would have ensured that data is comparable (Oesophageal Electrode Design, Page 235 “…to ensure data are comparable a constant interelectrode distance should be used…”) which would have ensured that data across multiple experiments are trials would be consistent and comparable.
Regarding Claim 4, it is noted that the combination of Stuebe in view Duricek and further in view of Luo would structurally yields 5 electrodes, including several “pairs” of adjacent electrodes that are all the same exact 1 cm adjacent distance apart. Any of the electrodes between the distal-most electrode and proximal-most electrode are interpreted as a middle electrode, because they are in the middle of the five electrode set. Any of these interpreted middle electrodes are interpreted as “common” electrode because the claim does not set forth any special functionality of the “common” electrode.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stuebe in view Duricek and further in view of US 3742594 A to Kleinberg
Stuebe in view Duricek teach the esophagus pH-myoelectricity combined electrode catheter of Claim 1 except for expressly disclose wherein the two pH sensors are both less than 1 cm in length.
However, Kleinberg teaches a catheter with electrodes/sensors that are part of a catheter body for pH detection (col. 1, lines 25-33), where the pH sensor is 1 mm to 3 mm in length (col. 3, lines 7-11: note “antimony” is the sensor itself, a specifical metal that provides pH sensing). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pH electrodes of Stuebe in view Duricek to be less than 1 cm of Kleinberg, because Kleinberg teaches at col. 1, lines 25-33 that such pH sensor size would be more robust and could reach many areas of biological systems.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791