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 Objections
Claim 1, 11 objected to because of the following informalities:
In claim 1 and 11, “a weight of at least one the determined …”, should read “at least one of the” as it is grammatically incomplete.
Appropriate correction is required.
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 1 and 11 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 1 and 11 recites, “indication of patient condition as a weighted function of …”, but no formula, bounds, mathematical relationship, or algorithm structure is disclosed to understand what that function is. The specification discloses only a linear weighted combination with time increasing/decreasing weights and a three-phase scheme (first period/ near-implant time period/post period), which are not representative of full breath of “a weighted function” as claimed without any limitation. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result, but the disclosure fails to sufficiently identify how the function is performed or the result is achieved. See, MPEP §§ 2163.03(V).
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 1 and 11 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.
Claim 1 recite, “the hybrid or relative determined relative baseline”, it is unclear if this refer back to “a hybrid or relative baseline” or a different more specific “relative baseline” is introduced, such that the metes and bounds of this claim is indefinite and the scope of the claim can’t be determined with reasonable certainty.
Claim 1 and 11 recite, “a weighted function” without sufficient corresponding structure/algorithm, the disclosure fails to define what that function is. As such, the metes and bounds of the claims are indefinite and the scope of the claim can’t be determined with reasonable certainty.
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 therefore, subject to the conditions and requirements of this title.
Claim 1-20 is/are rejected under 35 U.S.C. 101 because the claim invention is directed to
abstract ideas such as mental processes and/or mathematical concepts without significantly more.
Step 1: All the claims are directed either to a system/machine or to a method/process.
Step 2A, Prong One: The claims recite abstract ideas including steps such as "determine a representative value … determine a hybrid or relative baseline … determine an indication of patient condition as a weighted function …” (see e.g. claim 1) using a variety of physiological information gathered from a patient, which could be performed by the human mind and/or by a human of a diagnostician with physical aid such as pen and paper and/or certain methods of human activity.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process and/or mathematical concepts using generic processing technology and add insignificant extra-solution activity. Specifically: the step of "signal receiver circuit …" is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; and the steps of “assessment circuit” is considered insignificant post- solution activity since it merely outputs the result of the mental process using a generic output modality. Furthermore, merely carrying out mental steps using generic computing technology is well established to not amount to an integration into a practical application under the § 101 analysis. See, MPEP §§ 2106.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The Examiner takes official notice that these are basic, generic components which are well understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine, and conventional functions. The reference cited in this action also demonstrates the use of these conventional elements. As such, those additional elements cannot be considered "significantly more" than the judicial exception in Step 2B of the § 101 analysis.
Independent Claims 11 follow the same analysis above since they are substantially identical in scope.
All dependent Claims 2-10 and 12-20 also follow the same analysis above since the dependent claims merely further define the abstract ideas themselves, e.g. by adding additional mental steps or mathematical process.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220071507 A1 to Stolen et al. (hereinafter “Stolen”) in view of US 20080157980 A1 to Sachanandani et al. (hereinafter “Sachanandani”).
Regarding Claim 1, 10-11, and 20, Stolen disclose a medical device system and method (see Para 56: “an example system 200, such as a medical-device system”, see Abstract) comprising:
a signal receiver circuit (see Para 57: “a signal receiver circuit 202”, Fig.2) configured to receive physiologic information of a patient (see Para 57: “signal receiver circuit 202 can be configured to receive physiologic information of a patient (or group of patients) from one or more sensors 201”, and Para 05-06, 15, 56-57, Fig. 4) sensed by an implantable medical device implanted in the patient (see Para 35-36, 40-41, 61, 65, and 56 “a single device or a plurality of medical devices or monitors implanted in a patient's body”); and
an assessment circuit (see Para 57: “an assessment circuit 203 …”, Fig.2) configured to:
determine a representative value of the received physiologic information of the patient (see Para 82: “first physiologic information can include a single measurement, an ensemble value of multiple measurements … a composite measure of multiple values or different physiologic information, or a relative measure of one or more of these values”, and Para 57, 82-83);
determine a hybrid or relative baseline for the patient using the received physiologic information (see Para 90-93: “the first physiologic information can include the RR of the patient … a relative increase in the RR determined using a difference between a current RR value of the patient and a RR baseline of the patient … the RR baseline can include a long-term value, or a short-term value … the long-term, short-term, or baseline values can be determined as an average value of a number of previous samples”);
determine an indication of patient condition (see Para 05-25: “an assessment circuit configured to determine an indication of patient viral-respiratory disease using the received first and second physiologic information”) as a weighted function of (1) the representative value of the received physiologic information , (2) an absolute baseline, and (3) the hybrid or relative determined relative baseline, with a weight of at least one the determined absolute baseline or the determined relative baseline changing with time relative to a time of implant of the implantable medical device (see Para 12-13, 44-45, 83-97 (disclose weighting two different physiologic parameters relative to each other and threshold), Para 9-10 (first time period; second time period; Para 82 (daily value; a short-term value; long-term value)); and
provide the determined indication of patient condition to a user or process (see Para 59-60: “The assessment circuit 203 can be configured to provide an output to a user … assessment circuit 203 can be configured to determine an indication of patient condition”, and Para 98).
However, fails to specifically disclose determining the indication of patient condition as a weighted function of three inputs with weight changes as function of time.
Another reference, Sachanandani discloses a medical device system and method (see Abstract and Para 02) comprising:
a signal receiver circuit (see Fig.1, Para 69: “External sensors 107 may be used to measure patient physiological data …”);
an assessment circuit (see Fig.2):
determine an indication of patient condition as a weighted function (see Para 19, 31: “calculate the alert score using a weighted function of two or more detected alert statuses”, 91-97, 109, 116-117) of (1) the representative value of the received physiologic information (see Para 81: “weights in the weighted function … heart rate variability (HRV) …”, Para 99), (2) an absolute baseline (see Para 12, 30, 77), and (3) the hybrid or relative determined relative baseline (see Para 80, 84-85), with a weight of at least one the determined absolute baseline or the determined relative baseline changing with time relative to a time of implant of the implantable medical device (see Para 81-84: “… weights in the weighted function may be based on time ..”, 91-97, 72-77, 82-84).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filling date of the invention to combine Sachanandani teaching to modify the invention of Stolen in order to incorporate a weighted function of the representative value of physiologic information, absolute baseline, and relative baseline to indicate a patient condition, with weight of at least one baseline changing with time. Such modification would improve the accuracy and reliability of the patient condition assessment, particularly as time passes after implantation.
Regarding Claim 2 and 12, Stolen further disclose the modified medical device system of claim above, wherein the absolute baseline includes an imputed baseline stored or received by the medical device system (see Para 70, 75, 79: “assessment circuit may … as using data extracted from the one or more AMDs or data stored in a memory within the external system 305”, and Para 103).
Regarding Claim 3 and 13, Stolen further discloses the modified medical device system of claim above, wherein to determine the representative value of the received physiologic information of the patient includes to determine a value representative of at least a portion of at least one day of the received physiologic information of the patient (see Para 45, 82: “first physiologic information can include … a daily value … a short-term value … a composite measure of multiple values or different physiologic information, or a relative measure of one or more of these values”).
wherein to determine the relative baseline for the patient includes using information from the imputed baseline representative of a greater number of days than represented by the determined representative value (see Para 45, 82: “first physiologic information can include … a daily value … a short-term value (e.g., covering between 2 and 5 days, 2 and 7 days, etc.), a long-term value (e.g., a longer time period than the short-term … a composite measure of multiple values or different physiologic information, or a relative measure of one or more of these values”).
Regarding Claim 4 and 14, Stolen further discloses the modified medical device system of claim above, wherein to determine the value representative of at least a portion of at least one day of the received physiologic information includes to determine a value representative of one to three days of the received physiologic information of the patient, including a most recent one to three days (see Para 45: “the patient baseline or previous ranges can be discussed with respect to one or more weeks, or one or more values greater than one to three or five days. The data illustrated in FIG. 1 include dark lines illustrating short-term (e.g., 3-day) averages of physiologic information”, Para 82),
wherein the greater number of days includes at least 30 days prior to the one to three days of the received physiologic information of the patient, prior to or including the most recent one to three days (see Para 45: “the relative values of change can refer to a relative change greater than 10% of its previous baseline, or a spike or increase resulting in a value greater than a long-term (e.g., longer than a short-term, such as the preceding week, weeks, one to three months or more) range of sensor values”, Para 82),
wherein the assessment circuit is configured to provide an output of determined indication of patient condition to a user interface for display to the user or to a control circuit to control or adjust the process or function of the medical device system (see Para 47: “the determined viral-respiratory score … score crosses a threshold or exceeds a baseline … to determine or provide an alert … audio or visual indication on a display … to the patient, caregiver, or provider, or a medical device system can manage a relative change in geographic population viral-respiratory scores”, Para 59: “The assessment circuit 203 can be configured to provide an output to a user, such as to a display … other indication … configured to provide an output to another circuit … to control, adjust, or cease a therapy of a medical device”, Para 98).
Regarding Claim 5 and 15, Stolen further discloses the modified medical device system of claim above, wherein the assessment circuit is configured to determine the absolute baseline using information about the patient, the implantable medical device, or the received physiologic information, wherein the absolute baseline is different than the determined relative baseline (see Para 11-12, 20-21: “determining the relative increase in the respiration rate information comprises using a difference between the received respiration rate information of the patient and a respiration rate baseline of the patient … the assessment circuit is configured to determine the relative increase in the temperature information using a difference between the received temperature information of the patient and a temperature baseline of the patient”, Para 91-96).
Regarding Claim 6 and 16, Stolen further discloses the modified medical device system of claim above, wherein the assessment circuit is configured to determine the absolute baseline using the received physiologic information of the patient over a time period smaller than the number of days used to determine the relative baseline (see Para 13, 22: “the assessment circuit … over a first time period … respiration rate information of the patient over a second time period”).
Regarding Claim 7-8 and 17-18, Stolen further discloses the modified medical device system of claim above, wherein the weight of the absolute baseline decreases in time relative to the time of implant of the medical device and increases in time relative to the time of implant of the medical device (see Para 14, 23, 37-47, 52, Fig.1).
Regarding Claim 9 and 19, Stolen further discloses the modified medical device system of claim above, wherein, in a first period after implant of the implantable medical device, the weight of the absolute baseline in the weighted function is greater than the weight of the determined relative baseline, wherein, after a near-implant time period, the weight of the determined relative baseline in the weighted function is greater than the weight of the absolute baseline (see Fig.1 and Para 42-44: “a first alert 110 … After crossing the onset threshold 112, a reset threshold 113 activates (dotted line after the first alert 110), lower than the onset threshold 112 …”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220265219 A1 – Art relevant as a whole (see Abstract, Para 36, 42-44, 51-55, 61-68, 80).
US 20230301601 A1 - Art relevant as a whole (see summary)
US 10058708 B2 – Art relevant as a whole
US 20190069851 A1 – See Abstract, Summary, Para 41, 47, 119.
US 20170281097 A1 – see Abstract
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/I.J./ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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