DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2 and 4-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, at the time the application was filed, the applicant did not have possession of the claimed invention “configured to detect naturally occurring diaphragm myoelectric signals.” The specification does not use or define this term.
Regarding claim 2, at the time the application was filed, the applicant did not have possession of the claimed invention “a distance between the proximal pH sensor and a proximal-most one of the five diaphragm electromyographic electrodes is 5 cm”. The specification discloses a 5 cm distance between proximal pH sensor 2 and the electrode “located at the middle position,” i.e., electrode 5 (para. [0009], [0023]), this spacing is what places pH sensor 2 at 5 cm proximal of the esophageal sphincter when middle electrode 5 is at the level of the sphincter (para. [0022], [0024]), and each of electrodes 3-7 are 1 cm long and adjacent electrodes are 1 cm apart (para. [0023]), therefore, proximal-most electrode 7 is therefore closer to proximal pH sensor 2 than middle electrode 4 is. Therefore, the disclosed catheter cannot have a 5 cm distance to the proximal-most electrode, and nothing in the original disclosure describes that distance.
Regarding claim 6, at the time the application was filed, the applicant did not have possession of pH sensors that are of a length of 1 cm. The specification only sets forth that the pH sensors are “less than 1 cm in length” (para. [0022])
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, 2 and 4-7 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 term “naturally occurring” in claim 1 is a relative term which renders the claim indefinite. The term “naturally occurring” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim any type of diaphragm myoelectric signal.
Regarding claim 4, the limitation “a distal-most electrode” renders the claim indefinite. It is unclear if this is the same electrode as “a distal-most one of the first diaphragm electromyographic electrodes” recited in claim 2, or a new, distinct electrode. For purposes of examination the indefinite limitation has been deemed to claim the distal-most electrode of claim 2.
Regarding claim 4, the limitation “two electrodes” renders the claim indefinite. It is unclear if these are two of the five diaphragm electromyographic electrodes or additional, distinct electrodes. For purposes of examination the indefinite limitation has been deemed to claim two of the five diaphragm electromyographic electrodes.
Regarding claim 4, the limitation “a proximal-most electrode” renders the claim indefinite. It is unclear if this is the same electrode as “a proximal-most one of the five diaphragm electromyographic electrodes” recited in claim 2, or a new, distinct electrode, such as the reference electrode of claim 1, which is the most proximal electrode on the catheter body. For purposes of examination the indefinite limitation has been deemed to claim the proximal-most electrode of claim 2.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over GB 2463426 to Luo et al. (hereinafter, Luo) in view of Gastroesophageal reflux monitoring: pH and impedance to Tutuian et al. (hereinafter, Tutuian), and further in view of US 5477860 A to Essen-Moller (hereinafter, Essen).
Luo discloses an esophagus pH-myoelectricity combined electrode catheter, comprising inter alia:
an elongate catheter body (catheter 18, FIG. 1) having a distal end (distal end with holes 14, FIG. 1), a proximal end (proximal end with bifurcations 25-27 and connectors 28-30, FIGS. 1 and 3), and an outer surface (outer surface of catheter 18 carrying balloon 22 and electrodes 1-10 and 31, FIG. 1);
five diaphragm electromyographic electrodes disposed consecutively on the outer surface of the catheter body (diaphragm EMG electrodes 1-9 arranged in sequence with insulation gaps 12, FIGS. 1 and 4l electrodes 3-7 are interpreted as five consecutively disposed electrodes)
a reference electrode disposed on the outer surface of the catheter body (grounding/reference electrode 31, FIGS. 1 and 3) between the electrodes and the proximal end of the catheter body (electrode 31 located proximal of electrodes 1-10 and balloon 22, separated by gaps 15 and 32, FIG. 1);
five electromyographic-signal wires extending inside the catheter body (electrode leads 24 in lumen 20, FIGS. 2 and 3) and respectively electrically connecting the five diaphragm electromyographic electrodes to a bio-amplifier connector at the proximal end of the catheter body (leads 24 extending through bifurcation 25 to electrode lead connector 28, FIG. 3);
where the first diaphragm electromyographic electrodes are configured to detect naturally occurring diaphragm myoelectric signals (p. 4 “A distal electrode is to be grounded, and ten recording electrodes is to record ECG and diaphragmatic myoelectricity”);
where each of the five diaphragm electromyographic electrodes and the reference electrode has a longitudinal length of 1 cm (p. 5 “Each electrode is 1 cm in length”).
Luo positions electrode 5 at the level of the diaphragm (p. 2 “In use, when electrode 5 had been placed at the esophageal position equal to the diaphragm muscle, two leads which include electrode 5 would record the diaphragmatic myoelectricity signal”), with the distal end of the catheter in the stomach and an esophageal sensor (balloon 22) in the esophagus proximal of the electrodes and distal references electrodes (p. 2 “When electrode 5 locates in the diaphragmatic plane, according to the anatomic relationship, the balloon locates at the esophagus and the distal end of the tube is in the stomach”).
Luo discloses the claimed invention as set forth and cited above except for expressly disclosing:
(a) a distal pH sensor and a proximal pH sensor disposed on the outer surface of the catheter body, the distal pH sensor being positioned nearer the distal end of the catheter body than the proximal pH sensor, where the five diaphragm electromyographic electrodes are disposed between the distal pH sensor and the proximal pH sensor, and where the reference electrode is disposed between the proximal pH sensor and the proximal end of the catheter body; amd
(b) two pH-signal wires extending inside the catheter body and respectively electrically connecting the distal pH sensor and the proximal pH sensor to a pH processor connector at the proximal end of the catheter body.
However, regarding (a), Tutuian teaches an esophageal catheter having a distal esophageal pH sensor positioned 5 cm above the proximal boarder of the lower esophageal sphincter and a second pH sensor positioned in the stomach 10 cm below the LED to monitor gastric acidity (Conventional, Cathether-Based pH Monitoring, FIG. 1b, FIG. 8). Tutuian further teaches that the 5 cm esophageal position was reached by global consensus as the optimal depth for monitoring distal esophageal acid exposure (Conventional, Catheter-Based pH Monitoring, FIG. 1b, FIG. 8).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the catheter of Luo to include the distal (gastric) pH sensor and a proximal (esophageal) pH sensor on the outer surface of the catheter body, positioned as taught by Tutuian because:
1) Luo positions its electrodes at the level of the diaphragm and gastroesophageal junction (electrodes 5, FIG. 5). pH sensors placed 10 cm below and 5 cm above the electrodes would therefore be located distal and proximal of electrodes 3-7;
2) The proximal pH would lie in the esophageal region of Luo distal of reference electrode 31 (FIGS. 1 and 4), such that reference electrode 31 is located between the proximal pH sensor and the proximal end of the catheter body; and
3) Tutuian teaches that this placement is the accepted clinical configuration for monitoring esophageal acid exposure and intragastric activity (Conventional, Catheter-Based pH Monitoring, FIG. 1b, FIG. 1).
Regarding b), Essen teaches an esophageal catheter 10 having a pH sensor 14 with a conductor 32 extending inside tubular body 12, within lumen 73, to proximal end 34. At the proximal end 34 the conductor 32 passes through pH lead 42 and terminates at plug connector 44 for connection to a pH monitor (FIGS. 1 and 3). Essen further teaches measuring pH and respiratory parameters simultaneously with a single catheter in order to correlate reflux events with respiratory events (col. 3, lines 33-49).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to connect the pH sensors of Luo in view of Tutuian to a pH processor connector at the proximal end through conductors extending inside the catheter body, as taught by Essen because a pH sensor requires an electrical connection to a pH monitor to provide its measurement (Essen: conductor 32, connector 44, FIG. 1), Luo already teaches routing each sensing function through its own lumen to a dedicated proximal connector (Luo: lumens 19-21, connector 29-30, FIGS. 2 and 3) and Essen further teaches simultaneous pH and respiratory monitor with one catheter to correlate reflux with respiratory function in an accurate manner (col. 3, lines 33-49).
Allowable Subject Matter
Claims 2 and 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claim 3 is also allowable as being dependent claim 2.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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