DETAILED ACTION
This office action is in response to the communication dated 21 August 2024 concerning Application No. 17/403,496 filed on 16 August 2021.
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 .
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 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.
Status of Claims
Claims 1-3 and 57-75 are pending and currently under consideration for patentability; claims 4-56 previously were cancelled; and claims 74 and 75 have been added as new claims.
Response to Arguments
Applicant’s arguments filed 21 August 2024 have been fully considered, but they are not persuasive.
Applicant argues that one of ordinary skill in the art would have had no rational reason to modify the system of Maschino to arrive at one or more leads implanted in the epidural space. In support of this, Applicant argues that “merely suggesting that other locations of stimulation may be used for treating the disorder of the thyroid gland does not provide a rational reason for one of ordinary skill in the art to apply stimulation intended for these structures to other non-disclosed structures” (Arguments, p. 8). Applicant states that the actual disclosure of Maschino’s paragraph [0034], which was previously cited by the Examiner, describes that the implantable medical device 100 may be implanted in the patient at a suitable location. Applicant argues that implantable medical device 100 is different from lead 135, and “disclosure…related to implant location of IMD 100 is irrelevant to where a lead would be located” (Arguments, p. 9). Applicant summarizes that “knowledge that a lead can be placed in the epidural space would not have caused one of ordinary skill to deliver the stimulation described by Maschino for treating a disorder associated with the thyroid gland via a lead placed in the epidural space” (Arguments, p. 9). The Examiner respectfully disagrees. Regarding the “other locations of stimulation,” the Examiner relied on Maschino merely for disclosing that the implantable medical device and the associated lead may be implanted in various locations. The Examiner has not relied on Maschino for the exact location of implanting a lead in the epidural space, as the Lee reference was used for this teaching. But, Maschino suggests that modifications to the implantation site are permissible, thereby allowing a modification similar to that described by Lee. Regarding the relevancy of the implant location of IMD 100 and lead 135, the Examiner notes that, in addition to describing that IMD 100 may be implanted at a suitable location (Maschino, [0100]), Maschino also describes various locations for lead 135 ([0033] and figure 1 show leads implanted near a nerve branch that directly couples to the thyroid gland; [0043] describes leads which are coupled to electrodes implanted in the left and/or right branches of the vagus nerve). Therefore, the Examiner respectfully submits that Maschino suggests that the implant location of the implantable medical device and of the leads may be modified as necessary in order to stimulate an appropriate target.
Applicant argues that “one of ordinary skill in the art would not have arrived at the frequencies recited in claim 1 based on the teachings of Maschino, Lee, Su, or any proper combination thereof,” specifically the partially-overlapping pulse trains and respective frequencies of the first and second pulse trains as recited (Arguments, p. 10). The Examiner respectfully disagrees and maintains that it is the combination of the teachings of the respective references, in addition to the guidance provided in MPEP 2144.05, that obviates the respective limitations. For example, Maschino describes a wide range of frequencies which may be used, Su describes that multiple pulse trains can be used, Su further describes that the pulse trains may partially overlap with one another, and MPEP 2144.05 advises that the skilled artisan can discover the optimum or workable ranges of the pulse parameters via routine experimentation. Therefore, the Examiner respectfully maintains that Maschino in view of Lee and Su suggests the respective limitations.
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.
Claims 1-3 and 57-75 are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al. (US 2007/0027483 A1) in view of Lee (US 2013/0325084 A1) and Su et al. (US 2012/0197338 A1).
Regarding claims 1, 64, and 73, Maschino describes a system, method, and implantable device ([0002]) comprising
a signal generation module ([0041])
one or more leads each carrying one or more electrodes of a plurality of electrodes ([0043]: “IMD 100…is implanted and electrically coupled to the lead(s) 135, which are in turn coupled to the electrode(s) 140;” [0044]: “using the electrode(s) 140(1-n), the stimulus generator 150 may apply a predetermined sequence of electrical pulses”)
wherein the signal generation module is configured to implement an operating mode for delivering a first electric signal together with a second electric signal ([0045], [0068] - [0069]), wherein the first train of pulses is deliverable via a first set of electrodes of the plurality of electrodes and the second train of pulses is deliverable via a second set of electrodes of the plurality of electrodes ([0043] - [0044] describe the use of one or more leads with one or more electrodes; [0068] - [0069] describes stimulation using bursts of pulses; [0093] describes providing a stimulation signal that includes a pulse train), wherein a first frequency of the first train of pulses is between 200 Hz and 1,500 Hz, wherein a second frequency of the second train of pulses is between 20 Hz and 150 Hz (table 1 lists the frequency range of 0.5 Hz - 250 Hz; [0069]: “the signal repetition frequency may be programmed to be in a range of about 20-250 Hz”), and wherein the first set of electrodes is different from the second set of electrodes (figure 1, electrodes 140(1) and 140(n) are different electrodes; figure 2, electrodes 226 and 228; [0043]: “a particular type or a combination of electrodes may be selected as desired for a given application;” [0082], [0092]: “the stimulation controller 620 may also be capable of switching between various electrodes employed by the neurostimulator 205”)
Specifically regarding the second frequency being between 20 Hz and 150 Hz, the Examiner respectfully submits that, as the claimed range lies inside the range disclosed by the prior art (0.5 Hz to 250 Hz as described in Maschino’s [0069]), a prima facie case of obviousness exists (please see MPEP 2144.05).
Regarding claims 1, 64, and 73, although Maschino does not explicitly disclose wherein the first frequency is between 200 Hz and 1,500 Hz, Maschino does describe a frequency range between 0.5 Hz and 250 Hz (table 1; [0069]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate frequency range similar to that claimed when using the system described by Maschino, as doing so would be a matter of discovering the optimum or workable ranges by routine experimentation (please see MPEP 2144.05). The Examiner further submits that Maschino also lists, in Table 1, pulse widths in the range of 10 us to 1500 usec, which would correspond to frequencies of 667 Hz to 100 kHz.
Regarding claims 1, 64, and 73, Maschino does not explicitly disclose wherein the one or more leads are configured to be implanted within an epidural space of a patient. Maschino does, however, describe that the implantable medical device “may be implanted in the patient at a suitable location” ([0033], when describing that the implantable medical device may be a neurostimulator device capable of treating a condition associated with the hormonal activity of the thyroid gland). Maschino further describes that “although the IMD 100 is described in terms of cranial nerve stimulation, and particularly vagus nerve stimulation (VNS), a person of ordinary skill in the art would recognize that the present invention is not so limited,” continuing that “the IMD 100 may be applied to the stimulation of other cranial nerves, such as the trigeminal and/or glossopharyngeal nerves, or other neural tissue, such as one or more brain structures of the patient” ([0036]). Therefore, the Examiner respectfully submits that Maschino suggests that the implantable medical device may be implanted in any appropriate (suitable) location in order to provide stimulation to a particular nerve. One such implantation location is described by the Lee reference. Lee also describes an implantable system comprising a signal generation module and one or more leads, including wherein the one or more leads are configured to be implanted within an epidural space of a patient ([0011], [0065]). As Lee is also directed towards implantable stimulation systems and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the leads described by Maschino such that they were configured to be implanted in an epidural space of the patient, in a manner similar to that described by Lee, as doing so advantageously allows the resulting system to better target specific nerves or nerve branches for treatment.
Regarding claims 1, 64, and 73, Maschino does not explicitly disclose wherein a first train of pules of the first electric signal at least partially overlaps in time with a second train of pulses of the second electric signal. However, Su also describes an implantable system comprising a signal generation module and one or more leads carrying one or more electrodes ([0037]), including delivering a first train of pulses and a second train of pules such that the first train of pulses at least partially overlaps in time with the second train of pulses ([0249]). As Su is also directed towards implantable stimulation systems and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate partially overlapping pulse trains, similar to those described by Su, when using the system described by Maschino, as doing so advantageously allows the resulting system to provide a larger array of therapies to the user.
Regarding claims 2 and 65, Maschino describes wherein the signal generation module comprises at least a first and a second electric signal source ([0043], the IMD may be “a pair of devices”) and the one or more leads comprise at least a first subgroup and a second subgroup of the plurality of electrodes ([0043]). Although Maschino does not explicitly disclose wherein the first subgroup of electrodes is electrically coupled to the first electric signal source and the second subgroup of electrodes is electrically coupled to the second electric signal source, the Examiner respectfully submits that, as Maschino describes all of the components of multiple signal sources, multiple leads, and multiple electrodes, configuring the components in a manner similar to that recited would be a matter of adjusting, duplicating, and/or rearranging parts, with such matters having been held as being obvious to the skilled artisan (please see MPEP 2144.04).
Regarding claims 3 and 66, Lee describes providing a priming, or high-frequency, signal to a first subgroup of electrodes and a tonic, or low-frequency, signal to a second subgroup of electrodes ([0011]).
Regarding claims 57 and 67, Maschino describes wherein the first set of electrodes are selected to expose glial cells to the first electric signal, and wherein the second set of electrodes are selected to expose neurons to the second electric signal ([0037] - [0038] describe the locations of neurons and ganglia groups which may be targeted; the Examiner respectfully submits that, as ganglia may be comprised of glial cells, any stimulation provided to ganglia would also, in turn, stimulate the constituent glial cells).
Regarding claims 58 and 68, Su describes wherein each pulse of the first train of pulses is offset in time with each pulse of the second train (figure 14E; [0253]).
Regarding claims 59 and 69, Maschino describes wherein the first frequency of the first train of pulses is below 500 Hz (table 1; [0069]).
Regarding claims 60 and 70, Maschino describes wherein the second frequency of the first train of pulses is below 100 Hz (table 1; [0069]).
Regarding claims 61 and 71, Maschino describes wherein the first frequency of the first train of pulses is 1200 Hz and wherein second frequency of the second train of pulses is 50 Hz (table 1; [0069]).
Regarding claims 62 and 72, Maschino describes wherein a ratio of the first frequency of the first train of pulses to the second frequency of the second train of pulses is in a range from 20:1 to 40:1 (table 1; [0069]).
Regarding claim 63, Maschino further describes the signal generation module is configured to be implanted within a patient ([0032]).
Regarding claims 74 and 75, Lee further describes wherein delivering the first electrical signal and delivering the second electrical signal comprises providing electrical stimulation to at least one of a spinal cord or dorsal root ganglion ([0011], [0065]).
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792
Prosecution Insights