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 1-8 in the reply filed on 9/17/2025 is acknowledged.
Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/17/2025.
The status of the claim(s) are:
Claim(s) 9-15 are withdrawn;
Claim(s) 1-8 are examined on the merits;
Claim(s) 1-15 are presently pending.
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) 1, 3-4, 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denison (US 20150375006 A1; 12/31/2015; cited in IDS).
Regarding claim 1, Denison teaches a method for treating pain ([0034] “pain”), the method comprising:
delivering a predefined dosing pattern of a light signal by a subcutaneous light source (Fig. 1; Fig. 14; [0039]-[0040]; [0094]-[0095]);
transmitting the predefined dosing pattern of the light signal through the patient's body to an emitter (Fig. 1; [0039]-[0040]; [0094]-[0095]), wherein the emitter is located at a location proximal to a nerve related to the pain ([0034]; [0101]);
delivering the predefined dose of the light signal to a target to treat pain by neuromodulation ([0094]-0096]; [0101]).
Regarding claim 3, Denison teaches powering the subcutaneous light source by an external RF power source that is positioned over the subcutaneous system ([0118]-[0119] “RF-charging”; [0154] “proximal inductive interaction”).
Regarding claim 4, Denison teaches using a battery within the subcutaneous system to power the subcutaneous light source ([0084] “battery”; [0118]; [0154] “battery”).
Regarding claim 6, Denison teaches wherein the predefined dose comprises at least one of an optical power, a pulse width, a pulse shape, a frequency, an intensity, a cycling parameter comprising one or more period(s) of on time or off time, an amount of light delivered per unit time, a total amount of light to be delivered ([0038]; [0040]; [0095]; [0101]).
Regarding claim 7, Denison teaches wherein the subcutaneous system comprises a wireless transmitter to communicate with an external device to receive updates to the predefined dose (Fig. 4-5; [0097]; [0126]).
Regarding claim 8, Denison teaches wherein the subcutaneous light source comprises a non-transitory memory to store the predefined dose ([0108]).
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(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison as applied to claim 1 above.
Regarding claim 2, Denison does not explicitly teach repeating the delivering, transmitting, and delivering one or more of several times a day, daily, or weekly. Note that Denison teaches optical stimulation can be adjusted/repeated as necessary ([0038]; [0040]; [0094] “periodically interrogate implantable stimulator…to evaluation…modify the programs”; [0095]-[0096]; [0101]; [0141]; [0158]). As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[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")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison as applied to claim 1 above, in view of Matthews (US 20120245659 A1; 9/27/2012).
Regarding claim 5, Denison does not teach wherein the nerve related to the pain is the sphenopalatine ganglion and the pain is headache pain. Note Denison does teach treating migraine headaches ([0092] “migraine headaches”) by treating cranial nerves ([0034]). However, Matthews teaches in the same field of endeavor (Abstract; Fig. 4) wherein the nerve related to the pain is the sphenopalatine ganglion and the pain is headache pain ([0047] “sphenopalatine ganglion (“SPG”; [0048] “migraine headaches”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Denison to include this feature as taught by Matthews because this enables treating sphenopalatine ganglion with light to relieve headaches ([0047]-[0048]).
Conclusion
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792