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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Finland on 03 February 2022. It is noted, however, that applicant has not filed a certified copy of the FI22154914.0 application as required by 37 CFR 1.55.
Response to Arguments
Applicant’s arguments, see Amendment/Request for Reconsideration-After Non-Final Rejection, filed 06 October 2025, with respect to the rejection(s) of claim(s) 16 – 35 under 35 U.S.C. § 102/103 have been fully considered and are persuasive, in light of the amendments. Specifically, Applicant has amended the claims to recite that both the stimulating and the measuring are done “at a site of stimulation.” This appears to read over Finkel et al. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Finkel et al. (previously cited) in view of Bergethon et al. (US PGPUB 2009/0062685).
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.
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.
Claim(s) 16, 18 – 29, 31 – 33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finkel et al. (US PGPUB 2011/0245708 – previously cited) in view of Bergethon et al. (US PGPUB 2009/0062685).
Regarding claims 16, 29, and 33, Finkel discloses an apparatus, method and a non-transitory computer readable medium comprising program instructions stored thereon for causing an apparatus to perform the method, comprising: at least one processor (e.g. 900); and at least one memory (e.g. 902) storing instructions that, when executed by the at least one processor, cause the apparatus at least to: stimulate a biological sample using a plurality of electrical stimulating signals, the plurality comprising different values for one or more parameters wherein respective electrical stimulating signals are configured to cause a respective change in the biological sample wherein the respective change is optically detectable (e.g. ¶ 38 – 48); measure the optically detectable changes caused by the electrical stimulating signals by using one or more optical devices to detect the optically detectable changes (e.g. ¶ 50 – 53, 57, 58; NIRS is an optical emission and absorption technique that assesses hemodynamic changes…); and use the measurements obtained by the one or more optical devices and corresponding values for the one or more parameters of the electrical stimulating signals to generate a pain profile for the biological sample based on the optically detectable changes caused by the stimulation (e.g. ¶ 89, 91, 96). Finkel fails to teach that the stimulating and measuring are both done at the site of stimulation.
Bergethon teaches it is known to use an electrical nerve stimulator (e.g. 110) for delivering an electrical stimulation signal to a peripheral nerve (e.g. ¶ 18) and an optical detector (e.g. 128) for measuring, at the site of stimulation, the optically detectable changes caused by the stimulation (e.g. ¶ 18; near-infrared spectroscopy (NIRS) to examine the neuronal activity and vascular response of a peripheral nerve). It would have been obvious to one having ordinary skill in the art to modify the NIRS techniques taken at the cortical regions of the patient as taught by Finkel with the NIRS techniques taken at the site of stimulation as taught by Bergethon, since such a modification would provide the predictable results of non-invasively determining neuronal activation at the site (e.g. Bergethon ¶ 17).
Regarding claim 18, Finkel discloses the measurements obtained by the one or more optical devices are useable for generating a region of the pain profile below a threshold level of at least one of the electrical stimulating signals, and extrapolation of the measurements is useable for generating a region above the threshold level of the at least one of the electrical stimulating signals (e.g. ¶ 38, 68, 130).
Regarding claim 19, Finkel discloses the one or more parameters of the electrical stimulating signals comprises power (e.g. ¶ 38 and Fig. 2).
Regarding claim 20¸ Finkel discloses the generated pain profile is specific to the biological sample (e.g. ¶ 89, 91, 96).
Regarding claim 21, Finkel discloses the stimulation of the biological sample is spatially modulated for targeting one or more regions of the biological sample (e.g. Fig. 2).
Regarding claims 22, 23 31, 32, and 35, Finkel discloses the respective optically detectable changes caused by the electrical stimulating signals comprise one or more cellular or biomolecular level events comprising at least one of; cellular depolarization, transmembrane voltage changes, changes in nervous tissue, or electrolytic chemical imbalance (e.g. ¶ 38 – 48).
Regarding claim 24, Finkel discloses the respective optically detectable changes comprise a change in one or more optical properties of the biological sample (e.g. ¶ 89, 91).
Regarding claim 25, Finkel discloses the measurements obtained by the one or more optical devices and the corresponding values for the one or more parameters of the electrical stimulating signals are usable in combination with one or more qualitative pain indicators to generate the pain profile for the biological sample (e.g. ¶ 89 – 91).
Regarding claim 26, Finkel discloses controlling the electrical stimulating signals to vary one or more of frequency, duration, cycle, pattern, or shape of the electrical stimulating signals (e.g. ¶ 38 and Fig. 2).
Regarding claim 27, Finkel discloses the at least one memory and the instructions stored therein are configured to, with the at least one processor, further cause the apparatus to: obtain observation measurements from an optical device; and use the obtained observation measurements and the generated pain profile to determine a pain level for the biological sample (e.g. ¶ 89 – 91).
Regarding claim 28, Finkel discloses at least one of the one or more optical devices (e.g. ¶ 50 – 53, 57, 58).
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.
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.
Claim(s) 17, 30 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finkel et al. in view Bergethon et al. as applied to claims 16, 29, and 33 above, and further in view of Jarvik et al. (US PGPUB 2012/0108918 – previously cited).
Regarding claims 17, 30, and 34, Finkel in view of Bergethon teaches the invention as previously discussed, but fails to explicitly recite that the one or more optical devices used to detect the optically detectable changes comprise one or more optical coherence tomography devices.
Jarvik teaches it is known to use tomography devices to optically detect a pain response (e.g. ¶ 36 and 69). It would have been obvious to one having ordinary skill in the art to modify the optical devices as taught by Finkel in view of Bergethon with the tomography devices as taught by Jarvik, since such a modification would provide the predictable results of using a well known device to effectively provide tissue imaging.
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796