DETAILED ACTION
Claim Objections
Claims 1, 2, 5, 6, 8, 10, 11, 13, 16, 17, and 19 are objected to because of the following informalities: These claims contain phrases with what appears to be double or triple spacing between words, and/or spacing within a single word itself. See the following portion of claim 1, as an example:
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Appropriate correction is required.
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 16-20 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 16 recites at least one electrode patch mounted on a skin of a patient. Applicant is advised to amend the claim to recite that the at least one electrode patch is “adapted to be mounted on a skin …”
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 1-20 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.
Claim 1 recites setting a first threshold applicable to identifying a background or baseline amplitude. First, it’s unclear whether the background and baseline amplitudes are identical. If not, it is unclear whether only one of the two need to be identified as the claim further recites determining a volume above the baseline amplitude. Moreover, it would be unclear what the purpose of identifying a background amplitude would be, if they are not identical.
In addition, the claim recites identifying points within the EMG data set to yield one or more identified points, eliminating one or more of the identified peaks according to predefined criteria, and determining a volume above the baseline amplitude of each identified in each sequential time segment in the time series subsets. First, it’s unclear whether the applicant means volume (which is a three-dimensional measure) versus area (which is a two-dimensional measure), since the data isn’t in three dimensions. In addition, it’s unclear whether the determination of the volume is done on the original set of identified points or what remains after one or more have been eliminated. If the latter, it’s unclear how that would function in practice. Consider applicant’s own Fig. 39 as an example below, which the disclosure notes is used to illustrate the concept of cutting (i.e. eliminating) a peak:
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How would the determination of a volume as bounded by a baseline amplitude within the time series segment work after one of the peaks has been eliminated?
The claim also recites that the identified peaks are segregated into bins, which has the same issue of whether this is referring to all peaks, or just the ones remaining after certain ones were eliminated, the segregation being based on “predetermined frequency ranges associated with motor activity of specific gastrointestinal organs of the patient or time period as identified by activity associated with the patient”. The last step recites identifying which gastrointestinal organ is a source of the respective peaks associated with each of the bins. However, if the binning is not done on basis of the motor activity of specific gastrointestinal organs but the time period as identified by activity, it is unclear how it could be used to identify which gastrointestinal organ is a source of the respective peaks. Lastly, it’s unclear what a “activity associated with the patient” means, whether it’s physical or behavioral activity, or just GI motor activity.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
As to claim 2, the claim recites that the threshold is determined as a percentile rank of all data set. It is unclear whether the percentile rank is based on the original EMG data set, or whether it’s based on the values within the frequency spectrum, as recited in claim 1.
As to claim 3, the claim recites the background or baseline amplitude and the second threshold are based on predetermined fixed percentages of a highest value and a lowest value in the spectrum of the EMG data set. It is unclear whether both the first and second thresholds are based on the same single one of a highest or a lowest value, whether one uses a highest and the other the lowest value, or whether both thresholds use both values, or whether they can use a single one or both values in any combination (e.g. baseline amplitude based on just the lowest value and highest based on both values), and should they ever use both values, how they are usable together to obtain the threshold. In addition, while claim 1 recites a threshold applicable to identify a background or baseline amplitude, it doesn’t recite how the actual amplitude itself is obtained.
As to claim 4, the claim recites a piecewise threshold peak detector. As understood, a piecewise threshold peak detector would divide up the data into segments and apply different thresholds to find spikes. As claim 1 recites a single threshold, it is unclear what this limitation means.
As to claim 5, the claim recites eliminating identified peaks according to predefined values includes isolating one or more of the identified peaks. It’s unclear whether the isolated peaks are eliminated or whether the isolated peaks are the ones that are not eliminated. In addition, the last condition recites detecting that a value of the sides of a respective peak drops below a specified fraction of a maximum value. It is unclear what this maximum value is referring to, whether it’s the value of the peak itself (and thus different for each identified peak) or whether it some set value that’s independent of the peak value.
As to claim 6, the claim recites that the spectrum of the data set is scaled by a predetermined frequency. It is unclear what this means and the results could be dimensionally unclear. For example, does it scale by a frequency, a frequency value, spectral whitening?
As to claim 7, the claim recites that the spectrum includes a plurality of subranges, each one of which include different sets of criteria for thresholds, peak detection, elimination, and that the subranges are representative of physiologic activity associated with at least one gastrointestinal organ. It is unclear whether these subranges are the same as the bins based on predetermined frequency ranges associated with motor activity of specific gastrointestinal organs as recited in claim 1, or whether they are different. If the former, it’s also unclear whether this claim essentially specifies that it’s choosing to segregate by the predetermined frequency ranges of claim 1 or not. If the latter, it’s also unclear how the two limitations interact.
As to claim 8, it is unclear whether each subrange is defined after one or more peaks have been eliminated, or prior to the elimination. It’s also unclear, when the claim recites that “each subrange comprises one peak”, applicant intends to mean “at least one peak” as “comprising” is inclusive or open-ended, or whether applicant intends to mean “exactly one peak”. If the former, it’s unclear further limits claim 7 or not, as each subrange would necessarily have to include at least one peak to be utilized in further steps.
As to claim 11, it is unclear what is meant by “successive analysis runs”, in particular whether an “analysis run” is referring to each instance of the entirety of the method, or some subset. In addition, it is unclear whether each analysis run is done on the same data set or different data sets.
As to claim 12, the claim recites “multiple analysis runs are …”. First, it’s noted that claim 12 depends on claim 10, and there is no antecedent basis for multiple analysis runs. And even if it had been dependent on claim 11 instead, it would not be clear whether the “multiple analysis runs” are the same as the “successive analysis runs” or not. The claim also recites performing on a “first sequence”, but it’s unclear what a “first sequence” means, whether it’s referring to the first analysis run, or a first sequence of the data set. Lastly, it’s unclear how a single instance (e.g. in the first sequence), there could be sequential offset values.
As to claim 13, the claim lacks a main verb/predicate. For purposes of examination, it will be understood that the time segments used for analysis “are variable…”. In addition, a “sliding fixed length” appears to be self-contradictory, since something can’t be sliding and fixed. For purposes of examination, it will be understood as “sliding time segments of a fixed length”.
As to claim 14, the claim recites that the EMG data set comprises multiple channels and wherein frequencies observed in different channels are grouped based on a “respective proximity to one another”. Proximity in what sense? The physical distance between pairs of electrodes comprising each channel? The proximities of the frequencies?
As to claim 15, the claim recites the grouping of peak frequencies includes a selection of one or more of the multiple channels. It is unclear what it means to group when the claim allows for the selection of a single channel.
Claims 16-20 have similar issues to those identified above in their method counterparts.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites that each subrange has different sets of criteria for threshold, peak detection, and elimination. However, claim 1 recites setting a “first threshold” and “second threshold” for the EMG data set, so does not allow for multiple sets of criteria within the EMG data set.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Devanaboyina (US 2013/0046150) teaches a method of analyzing gastrointestinal EMG and identifying waveforms based on characteristics such as frequency or amplitude and differentiate signals between various parts of the gastrointestinal tract, such as the duodenum, ileum, colon, or others ([0056]). Chang (“Electrogastrography: Basic knowledge, recording, processing and its clinical applications”) teaches calculating a series of frequency spectra using sequential time-series segmented subsets (p506 – each line displaying a 256 sec portion), calculating a series of frequency spectra (p506 – running a short time Fourier transform), evaluating peaks (p507 – each spectrum being based on its peak to compute dominant frequency), segregating results into bins defined by predetermined frequency ranges (p508 – Table 1), summing within the bins (p508 – calculating percentages within categories, therefore accumulating classified spectra within each category), and eliminating certain identified peaks (p508 – removing harmonics, which reviewed from spectral analysis are double or triple the original dominant frequency, as they produce erroneous results).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 7/30/26
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