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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive. The Applicant amended the claims to recite 100 Hz to 600 Hz for a first frequency range and argued that the Kibler reference uses only high frequency trained pulses and that the different ranges are for priming in light of the Applicant’s specification. The Examiner respectfully disagrees that the reference does not disclose low frequency ranges, citing Para. 27, 30, 40, 58, 61, 79, And claim 4, which shows high (200 Hz to 100 kHz) and low frequencies (1 Hz to 200 Hz) providing stimulation in an interleaved pattern, which would fall under the first 100 Hz to 600 Hz and the second 20 Hz to 200 Hz ranges respectively. With regards to the priming phases, etc. contemplated in the specification, the claims are interpreted in light of the specification, but limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It would have been obvious for one of ordinary skill to apply Kibler’s established frequency ranges given that the low frequencies are well-known for paresthesia inducing SCS. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. In this case, the system is capable of providing interleaved stimulations regardless of the intended use contemplated in the Applicant’s specification. The 103 rejection is maintained below.
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.
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.
Claims 1-2, 4-5, 7-8, 14-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Grandhe US 2014/0277281 in view of Kibler et al. US 2018/0272133.
Regarding claims 1, 8, 14, and 16: Grandhe discloses a system which includes an IMD 14 (figures 14) which has within the casing stimulation generation circuitry 52/56 (figure 4) configured to generate and deliver electrical stimulation therapy (paragraph 0038) and processing circuitry 76 (figure 4) configure to control the stimulation generation circuitry (paragraph 0047) to: generate a first train P1 (figure 5A) of electrical stimulation pulses at a first frequency (2-50 kHz, paragraph 0058) to a first target tissue; and generate a second train P2 (figure 5A) of electrical stimulation pulses at a second frequency (2-1500 Hz) to a second target tissue different from the first target tissue; wherein at least some of the stimulation pulses of the first train of electrical stimulation pulses are interleaved with at least some of the electrical stimulation pulses of the second train of electrical stimulation pulses (paragraphs 0011 and 0044 and claim 10), and the first frequency is greater than the second frequency. The stimulation pulse train frequencies are different and delivered via the same electrode to the tissue, which is also how the stimulation is described in applicants disclosure. Under broadest reasonable interpretation it is assumed that these different frequencies can and potentially do target different tissues within a target region such as glia and neurons. Grandhe therefore discloses the claimed invention however Grandhe does not disclose a first frequency ranging from 100-600 Hz and a second frequency ranging from 20-200 Hz. Kibler however teaches of a neurostimulation device (paragraph 0020) which is configured to have a first pulse train which ranges from 200-1000 Hz and a second pulse train which ranges from 1-200 Hz (paragraph 00030). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Grandhe to include a first pulse train which ranges from 200-1000 Hz and a second pulse train which ranges from 1-200 Hz, as taught by Kibler, in order to either cause or not cause dorsal column depolarization (paragraph 0030) during neurostimulation. Not that the ranges claimed in the independent claims 1, 16 and 20 as well as the ranges found in dependent claims 21-22 overlap with the ranges of Kibler. MPEP 2144.05 discusses the obviousness of similar and overlapping ranges. In this case these are overlapping ranges with some that lie inside of the disclosed ranges of Kibler.
Regarding claims 2 and 17: Grandhe discloses generating a third train of electrical stimulation P3 (figure 5A) at a third frequency (2-5 kHz, paragraph 0058) to the target tissue, Grandhe further disclose interleaving the pulses of the various pulse trains (paragraphs 0011, 0044 and claim 10).
Regarding claim 4: Grandhe discloses that the first train and the third train of electrical stimulation pulses are generated together (they are generated via a common timing channel, paragraph 0058) the average frequency of the first and third pulse trains is disclosed as between 2-50 kHz and average frequency of the second pulse train is lower at 2-1500 Hz (paragraph 0058).
Regarding claim 5: Grandhe discloses that the third frequency P3 is greater than the second frequency P2 (paragraph 0058).
Regarding claim 7: Grandhe discloses the stimulation generation circuitry is configured to generate electrical stimulation pulses in a repeatable series of slots, the repeatable series of slots being repeatable over time for generating the first train of electrical stimulation pulses and the second train of electrical stimulation pulses, and wherein: the processing circuitry is configured to control the stimulation generation circuitry to generate the first train of electrical stimulation pulses by at least generating one pulse for a first slot of at least some of the repeatable series of slots that achieves the first frequency, and the processing circuitry is configured to control the stimulation generation circuitry to generate the second train of electrical stimulation pulses by at least generating one pulse for a second slot of at least some of the repeatable series of slots that achieves the second frequency. In figures 5A-5D of Grandhe disclose
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potential pulse patterns with each pattern comprising trains P1, P2, P3 and P4 with each having a separate time interval of T1, T2, T3 and T4 respectively. The time of the entire series of pulses is T, T contains T1, T2, T3 and T4. As is known in the art of spinal cord stimulation the time series T is repeated. Each pulse in figures 5A-5D includes 7 “slots”. In figure 5A slot 1 repeats with each train starting and filling slot 1, however in figure 5D a longer pulse width is used and slot two is also filled and considered to meet the claim limitations.
Claims 9-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grandhe US 2014/0277281 in view of Kibler et al. US 2018/0272133 and further in view of Gupte et al. US 2017/00173340.
Regarding claims 9-13 and 19: Grandhe/Kibler discloses the claimed invention however Grandhe/Kibler does not specifically disclose a first mode which is for a first period of time and a second mode for a second period of time. The first mode is the stimulation on time or the time the stimulation is delivered to the tissue whereas the second mode is a stimulation off time in which no stimulation is delivered. The ratio of on/off times ranging from 1:1 -1:3 and stimulation ranging from 1-30 minutes. Gupte however teaches of delivering pulse trains with an on time/off time ratio of 1:3 with 30 minutes on and 90 minutes off (paragraph 0127). Gupte further teaches that the times for on/off may be lower. Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Grandhe/Kibler to include stimulation on/off times ranging from 1:3 with 30 minutes or less on time, as taught by Gupte, in order to intermittently deliver therapy.
Allowable Subject Matter
Claims 3, 6, 18, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to disclose or render obvious all of the limitations of the independent claims in combination with changing an order of pulse of the first train with pulses of the third train of electrical stimulation pulses to adjust a pule pattern created by interleaving pulses.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796