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 1, Claims 1-10, in the reply filed on 03/12/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/12/2026.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20130289667 awarded to Wacnik et al, hereinafter Wacnik.
Regarding Claims 1 and 3, Wacnik teaches a method of ameliorating electrosensation while applying an electric field to a target region in a living body (Paras. 0025-0026), the method comprising: applying an alternating electric field (Para. 0051, “As an illustration, amplitude and pulse width could be gradually increased on an alternating basis among pulses, or bursts of pulses, such that one of amplitude and pulse width is increased or decreased for a first pulse or burst, then the other is increased or decreased for a second pulse or burst, and then the process repeats on an alternating basis over a series of pulses or bursts of pulses. In addition, ramping a stimulation parameter may not require each subsequent pulse to have a different parameter value than the previous pulse. Instead, consecutive pulses may still be defined by identical parameter values in some examples”) having a frequency between 50 kHz and 1 MHz to the target region during each of a plurality of intervals of time (Para. 0058, “For example, the pulse frequency may be between approximately 250 Hz and 1,000 Hz” and “the pulse frequency may be greater than 10,000 Hz”), wherein during each of the intervals of time, an amplitude of alternating electric field increases stepwise during a first portion of the interval (Para. 0059, “The relationship between the pulse frequency and the selected ramp period may vary based on the type of stimulation, the electrode combination, the location of the electrodes, and patient specific variables. In one example, the relationship between pulse frequency and the ramp period may be a linear relationship. In other examples, the relationship may be described as exponential, polynomial, or even step-wise”). Wacnik further teaches a range of steps used in an interval (Para. 0121, “Although ramp schedule 124 indicates that only three "teeth" may be provided within a 30-minute ramp period, a ramp period may include more frequent or less frequent teeth of the saw-tooth ramp. For example, each "tooth," or increase and decrease pair, may include a time period between approximately 0.5 seconds and 30 minutes. Shorter and longer teeth may be provided in other examples”, Examiner notes that this would lead to a range of 1 step to 3600 steps) and teaches wherein modifying the number of steps in an interval are a known design choice given the needs of a specific patient (Para. 0059). While Wacnik does not specifically teach wherein the interval includes at least 170 steps, or at least 200 steps, Wacnik recognizes that that adjusting the frequency and number of steps as needed is known in the art.
The specification does not disclose any criticality associated with claimed ranges of frequency between “50 kHz and 1 MHz” and interval includes at least “170 steps, or at least 200 steps.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wacnik, i.e. by using a frequency between 50 kHz and 1 MHz and 200 or more steps in an interval, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Regarding Claim 2, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches wherein each of the at least 170 steps has a height of less than 1 V (Para. 0098, “This ramp period may equal an approximate rate of increase of 0.6 volts per minute”).
Regarding Claim 4, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches wherein during each of the intervals of time, the alternating electric field has an amplitude that remains constant during a second portion of the interval that comes after the first portion of the interval (Fig. 8B, timeframe between 30 minutes/step 128 and 60 minutes/step 130, Para. 0122).
Regarding Claim 5, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches wherein during each of the intervals of time, the alternating electric field has an amplitude that decreases stepwise during a third portion of the interval that comes after the second portion of the interval (Para. 0158, “As shown in FIG. 14B, graph 290 indicates an example change in amplitude during a slow ramp in amplitude and a change in posture state of patient 12. Graph 290 may be similar to graph 260 of FIG. 14A; however, graph 290 provides a decrease to amplitude when the new posture state uses a lower amplitude value. In other words, patient 12 may be more sensitive to therapy in the new posture state and require a lower amplitude value for electrical stimulation to be efficacious. In this manner, IMD 14 may determine when patient 12 transitions from one posture state to a different posture state (e.g., from a standing up posture state to a sitting posture state)”).
Regarding Claim 6, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches using a plurality of intervals in a treatment session (Para. 0058) wherein the intervals can be as short as 1 minute (Para. 0058, “The ramp period at least partially defined by the ramp schedule may be between approximately one minute and 90 minutes”), and further teaches wherein modifying the number of intervals are a known design choice given the needs of a specific patient (Para. 0059). Wacnik does not teach wherein the plurality of intervals of time includes at least 100 intervals of time that all occur within one hour.
The specification does not disclose any criticality associated with claimed range of “at least 100 intervals of time that all occur within one hour.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wacnik, i.e. by performing at least 100 intervals in an hour, since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, see Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding Claim 7, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches wherein when the first portion of the interval ends during each of the intervals of time, the alternating electric field has an amplitude of at least 1 V/cm in at least a portion of the target region (Fig. 8b).
Regarding Claim 8, modified Wacnik makes obvious the method of Claim 1. Wacnik further teaches a frequency between 1 kHz and 1 MHz (Para. 0058), and wherein modifying the frequency of the system is a known design choice given the needs of a specific patient (Para. 0059). Wacnik does not teach wherein the frequency is between 100 KHz and 500 kHz.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wacnik, i.e. wherein the frequency is between 100 KHz and 500 kHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233], and Wacnik teaches above that adjusting the number of steps as needed is known in the art.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20130289667 awarded to Wacnik et al, hereinafter Wacnik, as applied to the claims above, and further in view of U.S. Patent Publication 20190117969 awarded to Schmidt et al, hereinafter Schmidt.
Regarding Claim 9, modified Wacnik makes obvious the method of Claim 1, wherein the electric field of the system can be modified in multiple ways as needed for a particular patient and/or treatment (Para. 0067). Wacnik does not teach wherein the alternating electric field is applied to the target region in a first direction during a first subset of the plurality of intervals of time, and wherein the alternating electric filed is applied to the target region in a second direction during a second subset of the plurality of intervals of time, wherein the second direction is offset from the first direction by at least 45 degrees.
However, in the art of stepped electrical fields (Paras. 0161-0162), Schmidt teaches wherein the alternating electric field is applied to the target region in a first direction during a first subset of the plurality of intervals of time, and wherein the alternating electric filed is applied to the target region in a second direction during a second subset of the plurality of intervals of time, wherein the second direction is offset from the first direction by at least 45 degrees (Para. 0130, “The electric field can be delivered to the site of a cancerous tumor along more than one vector. In some examples, the electric field can be delivered along at least one vector, including at least one of the lead electrodes. In some embodiments, at least two vectors with spatial diversity between the two vectors can be used. The vectors can be spatially separated (e.g., the vectors can be disposed at an angle with respect to one another) by at least about 10, 20, 30, 40, 50, 60, 70, 80 or 90 degrees”),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wacnik by Schmidt, i.e. by adjusting the electrical field of Wacnik as shown above in Schmidt, as Wacnik teaches the need of adjusting the electrical field of the system as needed for a particular treatment and patient above.
Regarding Claim 10, Wacnik modified by Schmidt makes obvious the method of Claim 9. Modified Wacnik makes obvious wherein during each of the intervals of time, the stepwise increase during the first portion of the interval includes at least 200 steps (see rejection to Claim 1 above), and Wacnik teaches wherein when the first portion of the interval ends during each of the intervals of time, the alternating electric field has an amplitude of at least 1 V/cm in at least a portion of the target region (Fig. 8b). Wacnik further teaches using a plurality of intervals in a treatment session (Para. 0058) wherein the intervals can be as short as 1 minute (Para. 0058, “The ramp period at least partially defined by the ramp schedule may be between approximately one minute and 90 minutes”), wherein modifying the number of intervals are a known design choice given the needs of a specific patient (Para. 0059). Wacnik does not teach wherein the plurality of intervals of time includes at least 100 intervals of time that all occur within one hour.
As indicated above, the specification does not disclose any criticality associated with claimed range of “at least 100 intervals of time that all occur within one hour.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wacnik modified by Schmidt, i.e. by performing at least 100 intervals in an hour, since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, see Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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