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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 9-18 in the reply filed on 01/23/2026 is acknowledged.
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.
Claim(s) 9-10, 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub No. 20110152877 to Bly (on IDS).
Regarding claim 9. (Original) Bly discloses an endotracheal stimulation system (abstract, para 0019, “neurostimulating lead”) comprising:
(a) a catheter (para 0019, “lead having a lead body 42”, 0021 “lead body includes a lumen”) wherein at least a distal portion of the catheter (para 0022 “distal portion 50”) comprises a pair of electrodes (para 0027 “distal portion includes one or more electrodes 56”), wherein the pair of electrodes are in electrical communication with a proximal portion of the system for connection to a control unit (para 0021 “the lead body 42 includes a plurality of conductors including individual wires, coils, or cables”, “each conductor is adapted to connect to an individual electrode 56 in a one-to-one manner allowing each electrode 56 to be individually addressable”, and para 0020, figs 5B-C), and wherein the distal portion of the catheter is biased to have a shape that is non-straight (figs 5B-C); and
(b) a guide sheath (para 0036, “guide catheter 110”) having a lumen surrounding at least a portion of the catheter (fig. 5C showing sheath covering/surrounding the lead body) and sized to fit within an endotracheal tube (fig. 5C showing guide catheter positioned within vessel 100), wherein the catheter is axially translatable with respect to the guide sheath (figs 5A-C); wherein the endotracheal stimulation system has:
(c) a constrained configuration when the distal portion of the catheter is within the guide sheath (fig. 5A), and wherein an axis of the catheter (fig. 5A, axis of portion of lead body 42 adjacent electrodes 56) and an axis of the guide sheath (fig. 5A, axis of guide catheter 110) are axially aligned (fig. 5A); and
(d) an unconstrained configuration when the distal portion of the catheter extends out of the guide sheath (fig. 5C), wherein at least a portion of the axis of the catheter (fig. 5C, axis of portion of lead body 42 adjacent electrodes 56) and the axis of the guide sheath (fig. 5C, axis of guide catheter 110) are askew (fig. 5C), such that the pair of electrodes contact a trachea of a subject (This limitation is understood as intended use without any structural differences with the device of Bly, it is understood that the device is capable of contacting trachea).
Regarding claim 10. (Original) Bly discloses the system of claim 9, wherein the pair of electrodes are bipolar (para 0021, “each conductor is adapted to connect to an individual electrode 56 in a one-to-one manner allowing each electrode 56 to be individually addressable”).
Regarding claim 15. (Previously Presented) Bly discloses the system of claim 9, wherein the catheter further comprises a lumen (para 0036 “lead body includes a lumen”).
Regarding claim 16. (Previously Presented) Bly discloses the system of claim 9, wherein the catheter is flexible, pliable, or both (para 0027).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 12-14, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20110152877 to Bly.
Regarding claim 12. (Previously Presented) Bly discloses the system of claim 9, but fails to explicitly disclose wherein the distal portion of the catheter comprises two or more pairs of electrodes. Bly discloses having one or more electrodes (para 0020). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to use four electrodes, since a mere duplication of essential working parts of device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). The motivation would be to ensure that stimulation is delivered to the desired location.
Regarding claim 13. (Original) Bly renders obvious the system of claim 12, wherein the two or more pairs of electrodes are evenly distributed along the length of the catheter(fig. 5C showing electrodes 56 being evenly distributed).
Regarding claim 14. (Previously Presented) Bly renders obvious the system of claim 12, wherein each of the two or more pairs of electrodes are separated by an offset distance of about 0.25 cm to about 16 cm (para 0034, figs 5A-C). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17. (Previously Presented) Bly discloses the system of claim 9, wherein the catheter has a non-straight shape in the unconstrained configuration with a diameter of about 1 mm to about 35 mm (fig. 5C, 0035). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18. (Original) Bly discloses the system of claim 17, wherein the catheter has a non-straight shape in the unconstrained configuration with a minimum, average, or maximum arc angle of about 90 degrees to about 360 degrees (fig. 5C).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20110152877 to Bly in view of 20030074039 to Puskas (on IDS).
Regarding claim 11. (Original) Bly discloses the system of claim 9, but fails to disclose wherein the pair of electrodes are monopolar.
Puskas, from a similar field of endeavor teaches an endotracheal stimulation system (para 0121) using balloon, basket, umbrella, and steerable devices [] used for maintaining ventilation during general anesthesia, having a pair of electrodes (Fig. 3C) wherein the pair of electrodes are monopolar (para 0047). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the electrodes of Bly with monopolar electrodes of Puskas, because doing so would allow for delivering stimulation signal over several contact points providing the predictable result of ensuring that stimulation is delivered to the desired location.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796