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 .
DETAILED ACTION
Election/Restriction
Group I, claim(s) 1-8, drawn to before/after event methods (G16H 50/30).
Group II, claim(s) 9-14, drawn to sleep methods (G16H 10/60).
Group III, claim(s) 15-20 , drawn to multi-day methods (G16H 50/50).
Inventions I-III are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are:
Group I is directed to A+B; group II is directed C+D and group III is directed to E+F.
Group I is directed to a method comprising calculation of a first peripheral hemodynamic index before an event affecting blood glucose, a second peripheral hemodynamic index after the event, and estimation of glucose metabolic capacity based on the change between the two index values.
Group II is directed to calculation of peripheral hemodynamic index values at a plurality of times during sleep and estimation of glucose metabolic capacity, peripheral hemodynamic regulation capacity, or sleep quality based on changes during sleep.
Group III is directed to calculation of peripheral hemodynamic index values continuously or intermittently over at least one day and estimation of glucose metabolic capacity or peripheral hemodynamic regulation capacity based on changes in the index values over the multi day period.
While it is not yet found that the method(s) of II and III are wholly directed to an abstract idea, they may implicitly involve similar abstractness, as recited in I, i.e. mathematical formulas for calculating certain indices. However, having some common variables and/or mathematical operations does not equate to the same designs, modes of operation, and effects.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
-the inventions require different search strategies.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner is appreciative of applicant electing Group I, and claims 9-20 are now withdrawn.
Summary
1. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the genus, does not reasonably provide enablement for the species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
2. Claims 1-8 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.
3. Claims 1-3 are rejected under pre-AIA 35 U.S.C. 102 as being anticipated by Liu (US 2019/0183365 A1).
4. Claim 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Tran (US 2021/0233656 A1).
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.
1. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the genus, does not reasonably provide enablement for the species. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The heart of the invention is “estimating a glucose metabolic capacity” which is a functional result, where such capacity would vary widely among mammals. Applicant has not enabled the full range of possible subjects without undue experimentation by a POSITA.
The claims encompass multiple sensor types, measurement positions, sampling strategies (continuous or intermittent), and embodiments without corresponding disclosure of how the invention should be implemented for these numerous alternatives. The specification does not provide enabling guidance for each significant claimed variation (e.g., differences in sensor wavelength, sampling rates, or placement, such as finger vs. wrist vs. earlobe), thereby requiring undue experimentation to practice the full claim scope.
Please identify or define the constituent “pulse wave feature quantity” elements with sufficient specificity (e.g., amplitude, time-to-peak, reflection index, augmentation index, dicrotic notch timing, rise time). Because claim 1 encompasses any pulse wave feature quantity used to calculate a peripheral hemodynamic index value, the species are not enabled.
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.
2. Claims 1-8 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 “event that affects a blood glucose level” is indefinite. What constitutes such an event (e.g., eating, exercise, medication)?
As per the “peripheral hemodynamic index value,” if this is a calculated metric from pulse wave data, please identify the formula or algorithm.
As per the “pulse wave feature quantity,” what features are measured (e.g., amplitude, slope, time intervals)?
In claim 3, the “low glucose metabolic capacity” should have a defined threshold (“below a given value”), and/or please describe how the “given value” could be derived from the pertinent examples, if any.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claims 1-3 are rejected under pre-AIA 35 U.S.C. 102 as being anticipated by Liu (US 2019/0183365 A1).
Liu discloses:
1. A method executed by a biological information measurement system, the method comprising:
([0008]-[0048])
before an event that affects a blood glucose level of a user, calculating a first peripheral hemodynamic index value of the user based on a pulse wave feature quantity determined from a pulse wave signal measured by a pulse wave sensor ([0033] and [0039]);
after the event that affects the blood glucose level of the user, calculating a second peripheral hemodynamic index value of the user based on the pulse wave feature quantity determined from the pulse wave signal measured by the pulse wave senso ([0033] and [0039]); and
estimating a glucose metabolic capacity of the user based on a change between the first peripheral hemodynamic index value and the second peripheral hemodynamic index value ([0021]-[0028], [0030]. [0031] and fig. 4A-D).
2. The method according to claim 1, wherein calculating the first peripheral hemodynamic index value and calculating the second peripheral hemodynamic index value includes calculating at a plurality of times continuously or intermittently from before the event to after the event ([0033] and [0039]).
3. The method according to claim 1, further comprising determining that the user has a low glucose metabolic capacity when the change between the first peripheral hemodynamic index value and the second peripheral hemodynamic index value of the user is below a given value ([0008]-[0048]).
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.
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.
4. Claim 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Tran (US 2021/0233656 A1).
To the extent that Liu doesn’t fairly suggest the additional features of claims 4-8, the examiner is providing the Tran reference. Tran teaches a health management system with sensors. In particular, Tran teaches vital signs sensors ([0025] 102 and 106 including but not limited to “heart to a distal point” ([0027]) and body temperature / sweating sensor ([0028]); glucose sensors; blood glucose ([0061]-[0087]); and user health ([0002], [0003], [0214]). It would have been obvious to one of ordinary skill in the art at the time of filing to augment/improve/upgrade the methods of Liu to include the techniques of Tran, and the results would have been predictable. One would have been motivated to make the combination for the user to have a plan to manage one’s own health without the direct oversight of a licensed medical professional.
Conclusion
Zhang teaches PPG signal processing for noninvasive glucose monitoring.
FDA warns against the accuracy of certain devices that do not pierce the skin.
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/MICHAEL FUELLING/Supervisory Patent Examiner