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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 17-26 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 17 recites “electrically stimulating body tissue of the user at one or more stimulation levels” and “the stimulation unit stimulates the user at one of the target intensity levels”. Specifically, the claiming of structures being in contact with or implanted within the body amounts to an inferential recitation of the body, which renders these claims non-statutory.
Claims 17-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is an analysis of subject matter eligibility according to MPEP 2106:
Step 1:
Independent claim 17 recites a system and thus is directed towards statutory categories of invention.
Step 2A Prong 1:
Claim 17 recite the following limitations:
calculating a set of target intensity levels for evoking the immediate electrotactile sensation based on a profile of the user;
the user to indicate when the immediate electrotactile sensation is felt when the stimulation unit stimulates the user at one of the target intensity levels;
determine the accuracy of the indicated target intensity level based on a calculated set of expected values of the target intensity levels for the immediate electrotactile sensation.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper. With calculating a set of target intensity levels, recording user feedback and determining the accuracy of the indicated targe intensity level based on a calculated set of expected values, a human could reasonably provide the calculations and assessment of accuracy of the indicated target intensity level. This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas.
Step 2A Prong 2:
Claim 17 recites the following additional elements:
a calculation unit for calculating a set of target intensity levels for evoking the immediate electrotactile sensation based on a profile of the user;
a discovery unit for the user to indicate when the immediate electrotactile sensation is felt when the stimulation unit stimulates the user at one of the target intensity levels; and
an assessment unit to determine the accuracy of the indicated target intensity level based on a calculated set of expected values of the target intensity levels for the immediate electrotactile sensation.
The limitations of “calculating a set of target intensity levels”, recording user feedback and “determining the accuracy of the indicated targe intensity level based on a calculated set of expected values” comprise functions that are merely implementation of a method or instructions that can be performed on a generic system, such as a processor or computer. The implementation of a mental process on a generic computer (in this case, once the mental process cited above is performed, one can readily ascertain how the mentally calculated data may be entered in a generic processor for evaluation and recommendation or implementation based on the data) provide no improvement to the functioning of a computer system as known in the medical art, thus as noted in MPEP 2106.05(a) the limitations do not amount to an improvement in the functioning of a computer. Similarly, these limitations comprises well-understood, routine and conventional activity with a processor, where it is common to have computer devices receive , evaluate and make “recommendations” or “implement” a change based on the data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application. Accordingly, even in combination, the additional element noted above (processor) do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. There is no recitation of an additional element (or combination of elements) that integrate the abstract idea of a mental process into a practical application.
The claimed limitations merely recite “a stimulation unit” for electrically stimulating body tissue of the user at one or more stimulation levels.
However, this is considered insignificant extra-solution activity to the judicial exception by presenting a step of providing information (ex. stimulation response data for “discovery unit for the user to indicate when the immediate electrotactile sensation is felt when the stimulation unit stimulates the user at one of the target intensity levels; and an assessment unit to determine the accuracy of the indicated target intensity level based on a calculated set of expected values of the target intensity levels for the immediate electrotactile sensation”) that can be analyzed by the abstract mental process “as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g))”.
There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Thus, the limitations of
There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Thus, the limitations of data displaying is considered extra solution activity.
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer components (processor and a monitoring interface). The same analysis applies here in 2B and does not provide an inventive concept.
Dependent claims:
Claims 18-26 are dependent claims that further limit the apparatus steps relating to calculating a set of target intensity levels, recording user feedback and determining the accuracy of the indicated targe intensity level based on a calculated set of expected values through a mental process. Accordingly, these claims do not integrate the abstract idea into a practical application for similar reasons to claim 17. These limitations comprise well-understood, routine and conventional activity in the medical diagnostic and treatment devices, where it is common to have computer devices to calculate operational parameters, record feedback and evaluate apparatus operational parameters and effects. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application.
Claim Rejections - 35 USC § 112
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.
Claims 23-24 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.
Regarding claim 23, the phrase "may contain" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 17-20 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gozani et al. (US 20130158627 A1).
As to claim 17, Gozani et al. discloses assessing the accuracy of a target stimulation intensity level of electrical nerve stimulation to a user that evokes an immediate electrotactile sensation from the user (Figure 9), said apparatus comprising: a calculation unit (within microprocessr-controlled circuitry of the stimulator 105; [0072, 0092]) for calculating a set of target intensity levels for evoking the immediate electrotactile sensation based on a profile of the user ([0090]; “where the target intensity has been determined by previously conducting electrotactile perception mapping for that patient (which identified the stimulation intensity I(s) associated with the sensation threshold) and then adding the desired intensity offset I(o) so as to establish the therapeutic stimulation intensity I(t) to be used for that patient.“ The examiner considers the “mapping” to generate a profile for the user.); a stimulation unit (stimulator, depicted as 105 in Figure 1; [0072, 92]) for electrically stimulating body tissue of the user at one or more stimulation levels ([0072, 0092]); a discovery unit (user interface elements, push button, depicted as 106 in Figure 1 and LEDs, depicted as 108 in Figure 1; [0068-0069, 0078]) for the user to indicate when the immediate electrotactile sensation is felt when the stimulation unit stimulates the user at one of the target intensity levels ([0068-0069, 0078, 0084]; the user elements, such as the push button, allows the user to modify the stimulation until the stimulation reaches the target intensity levels); and an assessment unit (part of the TENS device, [0093-0095]; Figure 9) to determine the accuracy of the indicated target intensity level based on a calculated set of expected values of the target intensity levels for the immediate electrotactile sensation (“upon entering the first therapy session 465, the therapeutic intensity level has already been automatically calculated for that patient. During the first phase 462 of first therapy session 465, the patient may adjust the stimulation intensity using the user interface controls (e.g., push button 106). The stimulation intensity at the end of the this first phase 462, which typically lasts for 3 minutes, is stored and becomes the therapeutic intensity level for the next therapy session 467. Habituation compensation, as previously described, occurs throughout the rest of the therapy session (i.e., during phase 464 of first therapy session 465) and subsequent therapy sessions 467. The patient has the option of repeating the electrotactile perception mapping phase 450, which will invoke a recalculation of the therapeutic stimulation intensity I(s), after one or more therapy sessions 467” [0095]; Thus, Gozani et al. discloses the TENS apparatus, depicted as 100 in Figure 1, determines the accuracy of the indicated target intensity level based on the calculated set of expected values of the target intensity levels).
As to claim 18, Gozani et al. discloses the immediate electrotactile sensation is the sensation threshold ([0046, 0080-0087]).
As to claim 19, Gozani et al. discloses the immediate electrotactile sensation is the pain threshold or the tolerance threshold ([0079-0083, 0092-0093]).
As to claim 20, Gozani et al. discloses the profile of the user includes at least one of the following: age, gender, body mass index, painful health conditions, chronic pain locations, pain frequency, pain patterns, sensitivity to weather and weather changes, pain ratings, pain interference scores, body temperature, weather conditions, and previously determined target stimulation intensity levels ([0088]).
As to claim 23, Gozani et al. discloses may contain an optional feedback unit to provide a feedback to the user on the accuracy of the indicated target intensity level ([0069, 0092]).
As to claim 24, Gozani et al. discloses wherein the feedback unit prompts the user to repeat the process for indicating a target intensity level if the accuracy is below a threshold ([0092]).
As to claim 25, Gozani et al. discloses the stimulation unit stimulates the user with a set of intensity levels for determining the target intensity level, wherein the intensity levels of the set of intensity levels are sequentially presented to the user ([0090]; “ramp up to the target intensity”).
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.
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.
Claims 21-22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (US 20130158627 A1).
As to claims 21-22, Gozani et al. discloses the invention substantially as claimed with the set of expected values of target intensity levels, but does not explicitly disclose the set of expected values of target intensity levels is determined based on a collection of indicated target intensity levels from a selected group of users that are formed based on similarity of their user profiles with the profile of the user. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the target intensity levels in be initially selected group of users that are formed based on similarity of their user profiles with the profile of the user in order to provide the predictable results of optimizing the treatment to meet specific patient therapeutic needs and requirements.
As to claim 26, Gozani et al. discloses the invention substantially as claimed but does not explicitly disclose “a second calculation unit for updating a likelihood function for the set of intensity levels to be the target intensity level to evoke the immediate electrotactile sensation from the user” with a “control unit is further configured to update the target stimulation intensity level based on the updated likelihood function”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus of Gozani et al. to include a second calculation unit since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 (see MPEP 2144.04). Furthermore, such a modification would ensure the apparatus provides sufficient treatment to meet specific patient therapeutic needs and requirement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796