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 .
Response to Amendment
This office action is responsive to the amendment filed on 2/19/2021. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1 has/have been amended;
Claim(s) 9-15 is/are cancelled;
Claim(s) 16-21 is/are new;
Claim(s) 1-8, 16-21 is/are presently pending.
Response to Arguments
With regard to claim rejections under 35 USC 102 and/or 103, Applicant’s arguments have been fully considered but are moot in light of new grounds of rejection due to claim amendment(s).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 19 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 recites “wherein predefined dose has a low average optical power”; however, there is no support readily found in the instant specification nor drawings to support this limitation.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “low average optical power” in claim 19 is a relative term which renders the claim indefinite. The term “low average” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim(s) 1-8, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison (US 20150375006 A1; 12/31/2015; cited in IDS; cited in previous office action) in view of Matthews (US 20120245659 A1; 9/27/2012; cited in previous office action).
Regarding claim 1, Denison teaches a method for treating pain at a target pain location in a subject ([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]).
Denison does not teach wherein the emitter is located at a location sufficient to directly deliver the predefined dose of the light signal to a target peripheral nerve related to the pain; and
delivering the predefined dose of the light signal directly to the target peripheral nerve to treat pain by neuromodulation, wherein the target pain location is located distal to a location of the target peripheral nerve.
Note that Denison teaches targeting a variety of tissues including peripheral nerves ([0034]). However, Matthews teaches in the same field of endeavor (Abstract; Fig. 4) wherein the emitter is located at a location sufficient to directly deliver the predefined dose of the light signal to a target peripheral nerve related to the pain ([0050]); and
delivering the predefined dose of the light signal directly to the target peripheral nerve to treat pain by neuromodulation, wherein the target pain location is located distal to a location of the target peripheral nerve ([0050]).
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 variety of pain by using light to block or inhibit the signal ([0050]).
Regarding claim 2, the combination of Denison and Matthews 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 does Matthews ([0046] “Treatments can also be repeated on an as needed basis”). 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)).
Regarding claim 3, in the combination of Denison and Matthews, 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, in the combination of Denison and Matthews, Denison teaches using a battery within the subcutaneous system to power the subcutaneous light source ([0084] “battery”; [0118]; [0154] “battery”).
Regarding claim 5, in the combination of Denison and Matthews, Matthews teaches wherein the nerve related to the pain is the sphenopalatine ganglion and the pain is headache pain ([0047] “sphenopalatine ganglion (“SPG”; [0048] “migraine headaches”).
Regarding claim 6, in the combination of Denison and Matthews, 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, in the combination of Denison and Matthews, 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, in the combination of Denison and Matthews, Denison teaches wherein the subcutaneous light source comprises a non-transitory memory to store the predefined dose ([0108]).
Regarding claim 17, in the combination of Denison and Matthews, Matthews teaches wherein delivery of the predefined dose of the light signal directly to the target peripheral nerve results in a nerve block that does not require a thermal increase ([0043] “relatively low power…do not generate a great deal of thermal energy”; [0050]).
Regarding claim 18, the combination of Denison and Matthews teaches wherein the predefined dose comprises a wavelength of about 600-1600 nm (Denison [0037] “infrared light having a wavelength of between about 700 nm and about 300 µm”; Matthews [0013] “infrared spectrum in the wavelength range of approximately 300 nanometers (“nm”) to approximately 1200 nm…wavelength of approximately 830 nm”). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
Regarding claim 19, in the combination of Denison and Matthews, Matthews teaches wherein predefined dose has a low average optical power ([0043] “relatively low power”).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison and Matthews as applied to claim 1 above, and further in view of Lothet (US 20210128913 A1; Filed 4/16/2018).
Regarding claim 16, the combination of Denison and Matthews does not teach wherein the peripheral nerve contains at least one C-fiber. However, Lothet teaches in the same field of endeavor (Abstract; Fig. 2; [0056])) wherein the peripheral nerve contains at least one C-fiber ([0058]). 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 and Matthews to include this feature as taught by Lothet because this enables pain therapy at this location ([0056]-[0058]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison and Matthews as applied to claim 1 above, and further in view of Schneider (US 20110071601 A1; 3/24/2011).
Regarding claim 20, the combination of Denison and Matthews does not teach wherein the target pain location is a hand and the target peripheral nerve is one of an ulnar nerve, a median nerve, or a radial nerve located in a wrist or an arm of the subject. However, Schneider teaches in the same field of endeavor (Abstract; [0005]; [0015]) wherein the target pain location is a hand and the target peripheral nerve is one of an ulnar nerve, a median nerve, or a radial nerve located in a wrist or an arm of the subject (Fig. 1-2; Fig. 10-11; [0030; [0057]; [0071]). 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 and Matthews to include these features as taught by Schneider because this enables treating pain in these areas ([0034]; [0076]; claim 4; claim 6).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Denison and Matthews as applied to claim 1 above, and further in view of John (US 20200139118 A1; 5/7/2020).
Regarding claim 21, the combination of Denison and Matthews does not teach wherein the target pain location is a foot and the target peripheral nerve is a saphenous nerve located in a leg of the subject. However, John teaches in the same field of endeavor (Abstract; [0004]; [0154] “light source”) wherein the target pain location is a foot (Fig. 10b; [0105]; [0328]) and the target peripheral nerve is a saphenous nerve located in a leg of the subject (Fig. 10b; [0057]; [0192] “laser stimulation…saphenous”; [0328]). Thus it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the teaching of Denison and Matthews to include these features as taught by John because this enables treating pain in these areas (Fig. 10b; [0057]; [0105]; [0192] “laser stimulation…saphenous”; [0328]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
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