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 .
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.
Claims 1-11, 13-21, 25, 27, and 30 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Waataja et al. (International Publication No.: WO 2020/214982 A1).
Regarding claim 1, Waataja discloses a system for regulating at least two
neuronal targets (e.g. pg. 7, lines 28-34):
a first neuroregulator (e.g. Fig. 1B – electrical lead assembly 106)
that applies a stimulation or a conduction block to a first neuronal target (e.g. pg. 7, lines 28-34 – regulating nerve activity through stimulation);
and a second neuroregulator (e.g. Fig. 1B – electrical lead assembly 106a) that applies a stimulation or a conduction block to a second neuronal target (e.g. pg. 7, line 30) that is different from the first neuronal target (e.g. pg. 9, lines 16-18), wherein the stimulation or conduction block of the first neuronal target works in cooperation with the stimulation or conduction block of the second neuronal target to treat a medical condition (e.g. pg. 7, lines 33-34 – the first electrical signal and the second electrical signal are applied concurrently or simultaneously; pg. 9, lines 19-24).
Regarding claim 2, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuronal target and the second neuronal target each comprise one or more sympathetic nerves (e.g. pg. 9, lines 12-15 – sympathetic nerves).
Regarding claim 3, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuronal target and the second neuronal target each comprise one or more parasympathetic nerves (e.g. pg. 9, lines 12-15 – vagus nerves are parasympathetic nerves).
Regarding claim 4, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuronal target comprises one or more sympathetic nerves and wherein the second neuronal target comprises one or more parasympathetic nerves (e.g. pg. 9, lines 12-18).
Regarding claim 5, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the stimulation or conduction block applied to the first neuronal target is of a different duration than that stimulation or conduction block applied to the second neuronal target (e.g. pg. 8, lines 24-26; pg. 107, lines 14-15).
Regarding claim 6, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuroregulator applies the stimulation to the first neuronal target and the second neuroregulator applies the stimulation to the second neuronal target (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 7, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuroregulator applies the conduction block to the first neuronal target and wherein the second neuroregulator applies the conduction block to the second neuronal target (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 8, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuroregulator applies the conduction block to the first neuronal target and wherein the second neuroregulator applies the stimulator to the second neuronal target (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 9, Waataja discloses the system of claim 8 as discussed
above, and Waataja further teaches wherein the first neuronal target comprises a hepatic nerve and the second neuronal target comprises the celiac branch of the posterior vagus nerve (e.g. pg. 9, lines 12-15 and lines 25-34).
Regarding claim 10, Waataja discloses the system of claim 1 as discussed
above, and Waataja further teaches wherein the first neuroregulator is an electrical neuroregulator (e.g. pg. 2, lines 6-8; pg. 7, lines 28-34; pg. 10, lines 8-16).
Regarding claim 11, Waataja discloses the system of claim 10 as discussed
above, and Waataja further teaches wherein the second neuroregulator is an electrical neuroregulator (e.g. pg. 2, lines 6-8; pg. 7, lines 28-34; pg. 10, lines 8-16).
Regarding claim 13, Waataja discloses a method for treating a medical condition (e.g. abstract; pg. 2, lines 26-28 – treating conditions associated with disorder of blood glucose; pg. 9, lines 19-24), comprising:
neuromodulating, with a stimulation or a conduction block, (e.g. pg. 7, lines 28-34 – regulating nerve activity through stimulation)
a first neuronal target (e.g. pg. 7, lines 29-30 – first nerve branch/fiber);
and neuromodulating, with a stimulation or a conduction block, (e.g. pg. 7, lines 28-34 – regulating nerve activity through stimulation)
a second neuronal target (e.g. pg. 7, line 30 – second nerve branch/fiber), wherein the second neuronal target is different from the first neuronal target (e.g. pg. 9, lines 16-18),
and wherein the neuromodulation of the first neuronal target works in cooperation with the neuromodulation of the second neuronal target to treat a medical condition (e.g. pg. 7, lines 33-34 – the first electrical signal and the second electrical signal are applied concurrently or simultaneously; pg. 9, lines 19-24).
Regarding claim 14, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein the first neuronal target and the second neuronal target each comprise one or more sympathetic nerves (e.g. pg. 9, lines 12-15 – sympathetic nerves).
Regarding claim 15, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein the first neuronal target and the second neuronal target each comprise one or more parasympathetic nerves (e.g. pg. 9, lines 12-15 – vagus nerves are parasympathetic nerves).
Regarding claim 16, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein the first neuronal target comprises one or more sympathetic nerves and wherein the second neuronal target comprises one or more parasympathetic nerves (e.g. pg. 9, lines 12-18).
Regarding claim 17, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein neuromodulating the first neuronal target comprises neuromodulating with the stimulation and wherein neuromodulating the second neuronal target comprises neuromodulating with the stimulation (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 18, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein neuromodulating the first neuronal target comprises neuromodulating with the stimulation and wherein neuromodulating the second neuronal target comprises neuromodulating with the conduction block (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 19, Waataja discloses the method of claim 13 as discussed above, and Waataja further teaches wherein neuromodulating the first neuronal target comprises neuromodulating with the conduction block and wherein neuromodulating the second neuronal target comprises neuromodulating with the conduction block (e.g. pg. 11, lines 1-4; pg. 38, lines 13-22).
Regarding claim 20, Waataja discloses a system for regulating at least two neuronal targets (e.g. pg. 7, lines 28-34):
a first implantable electrical neuroregulator (e.g. Fig. 1B – electrical lead assembly 106) that applies a stimulation or a conduction block to a first neuronal target (e.g. pg. 7, lines 28-34 – regulating nerve activity through stimulation);
and a second implantable electrical neuroregulator (e.g. Fig. 1B – electrical lead assembly 106a) that applies a stimulation or a conduction block to a second neuronal target (e.g. pg. 7, line 30) that is different from the first neuronal target (e.g. pg. 9, lines 16-18),
wherein the stimulation or conduction block of the first neuronal target works in cooperation with the stimulation or conduction block of the second neuronal target to treat a medical condition (e.g. pg. 7, lines 33-34 – the first electrical signal and the second electrical signal are applied concurrently or simultaneously; pg. 9, lines 19-24).
Regarding claim 21, Waataja discloses a method of sensing biological activity to trigger neuromodulation (e.g. pg. 41, lines 8-13) the method comprising the steps of:
obtaining a change in biological activity from a sensor (e.g. pg. 41, lines 8-13 and 19-24);
initiating the neuromodulator to initiate at least one signal to a target nerve, organ or tissue (e.g. pg. 41, lines 8-13 and 19-24), thereby altering the biological activity to a predetermined level, where the signal is stopped (e.g. pg. 41, lines 8-13, 19-34; pg. 42, lines 8-11).
Regarding claim 25, Waataja discloses the method of claim 21 as discussed above, and Waataja further teaches wherein the signal is from at least two electrodes (e.g. pg. 41, lines 29-34; pg. 42, lines 1-7) and wherein the at least two electrodes are initiated at the same time (e.g. pg. 7, lines 33-34; pg. 41, lines 29-34; pg. 42, lines 1-7).
Regarding claim 27, Waataja discloses the method of claim 21 as discussed above, and Waataja further teaches wherein the at least two electrodes are initiated in a signally protocol (e.g. pg. 74, lines 27-34) selected from a group consisting of; wherein one electrical signal initiates a block and the other electrical signal initiates a stimulation, one electrical signal initiates a block and the other electrical signal initiates a block and one electrical signal initiates a stimulation and the other electrical signal initiates a stimulation (e.g. pg. 38, lines 13-22; pg. 74, lines 27-34).
Regarding claim 30, Waataja discloses the method of claim 21 as discussed above, and Waataja further teaches wherein the sensor detects a change in biological activity selected from a group comprising blood glucose, heart rate, blood pressure, respiration, motion, CNS neuronal electrical signals, peripheral nerve signals and combinations thereof (e.g. pg. 41, lines 19-20; pg. 42, lines 8-11).
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.
Claim 12 is rejected under 35 U.S.C 103 as being unpatentable over Waataja and further in view of Bright et al. (US Pub.: 2019/0038646 A1).
Regarding claim 12, Waataja discloses the system of claim 10 as discussed
above. However, Waataja does not explicitly teach wherein the second neuroregulator is a non-electrical neuroregulator.
Bright, in a same field of endeavor of neuromodulation systems, discloses wherein the second neuroregulator is a non-electrical neuroregulator (e.g. paragraphs 0005, 0018, 0132 – chemical neuromodulation (i.e. chemical neuroregulator)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Waataja to incorporate wherein the second neuroregulator is a non-electrical neuroregulator, as taught and suggested by Bright, in order to reduce collateral damage to surrounding tissue during therapy, reduce the cost of treatment, as well as to be able to treat additional conditions such as hemorrhagic stroke, arrhythmias, and myocardial infarctions (Bright, paragraphs 0004-0005 and 0132).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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