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 .
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.
Response to Arguments
Applicant's arguments filed April 3, 2026 have been fully considered but they are not persuasive.
Regarding the 112f and 112b:
Per MPEP 2181 I. A.: “It is important to remember that there are no absolutes in the determination of terms used as a substitute for “means” that serve as generic placeholders. The examiner must carefully consider the term in light of the specification and the commonly accepted meaning in the technological art. Every application will turn on its own facts.” It is unclear whether some of the circuitries are meant to be hardware or software or a combination of both thus necessitating the 112f. Regardless it is just an interpretation and no corresponding 112a/b rejections are provided for “processing circuities” or “accelerometer circuitries”.
Paragraph 0108 of Applicant’s specification provides no structure for communication circuitry. The only structure disclosed in Paragraph 0108 is corresponding to a computer network, the Medtronic CareLink Network. And Paragraph 0108 differentiates computer network from communication circuitry as separate structures. Paragraph 0143 of Applicant’s specification provides no structure for communication link.
These paragraphs merely mention the terms interpreted under 112f and subsequently rejected under 112b. But that is not the issue at hand. The issue isn’t whether the specification uses the claim terms, the issue is whether the specification has any details regarding the specific structure for these claim terms. These paragraphs do not detail any structure. No structure for communication circuitry is provided in the disclosure.
Regarding the 101:
Per MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II.
No clear improvement is reflected in the claims.
Further per the MPEP: “Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d).”
The claims merely acquire data with conventional equipment, perform generic analysis claimed at a high level of generality (ie merely stating determine(ing) or based on without any specifics what exactly is the calculation or analysis either of those terms are meant to mean), and then outputting data. This is clearly ineligible subject matter. As per MPEP 2106.04(a)(2) III A: Examples of claims that recite mental processes include:
• • a claim to “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);
The claimed invention is clearly analogous to the above and thus the 101 rejection stands.
Response to Amendment
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-‘one or more accelerometer circuitries configured to generate at least one signal’ in claim 21 interpreted to be an accelerometer per Paragraphs 0120-0122 of the specification
-‘one or more processing circuitries’ in claims 21, 28, 35, 36, 38, and 40 interpreted to be “Processing circuitry 200 may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field-programmable gate arrays (FPGAs). In some examples, processing circuitry 200 may include multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and/or analog circuitry.” per Paragraph 0112 of the specification
-‘communication circuitry’ in claim 30 (no clearly linked structure is provided within the specification)
-‘transmit, via a communication link’ in claim, 21, 31, 38, and 40 (no clearly linked structure is provided within the specification)
-‘accelerometer circuitry configured to generate at least one signal’ in claim 40 interpreted to be an accelerometer per Paragraphs 0120-0122 of the specification
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 21-40 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.
Per claims 21, 30, 31, 38, and 40: Claim limitation “communication circuitry” and “communication link” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Paragraph 0108 of the specification is the closes thing to discussing the structure of these components (“Communication circuitry 168 includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as an external device 30 or another IMD or sensor.”). As seen no clear structure is provided for either of these terms. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claimed invention in claims 21-40 are directed to statutory subject matter as the claims recite a device (claims 21-30 and 40) and a method (claims 31-39).
Step 2A, Prong One
Regarding claims 21-40, the recited steps are directed mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Specifically from claims 21, 31, and 40:
detect(ing), based upon the at least one signal, a Sit-to-Stand transition of the patient;
determine(ing), based on the at least one signal, that the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition;
based on the determination that the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one signal by determining at least one of a) a first step taken by the patient after the Sit-to- Stand transition based on the at least one signal, b) a peak or valley in the at least one signal, c) an amplitude of a peak to a valley in the at least one signal, d) a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) a slope of the at least one signal; and
transmit…data that is usable by the external computing device to generate an output that is based at least in part on a likelihood the patient may fall.
These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
Examples of ineligible claims that recite mental processes include:
• a claim to “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, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Step 2A, Prong Two
This judicial exceptions (abstract ideas) in claims 21-40 are not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for detect(ing), determine(ing), process, and transmit merely invoke a computer as a tool.
•The data-gathering step (generate at least one signal) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for detect(ing), determine(ing), process, and transmit.
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer to detect(ing), determine(ing), process, and transmit. The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Step 2B
The additional elements are identified as follows: ‘an implantable medical device’ in claims 21, 31, and 40; ‘one or more accelerometer circuitries configured to generate at least one signal’ in claims 21 and 31; ‘one or more memories’ in claims 21 and 31; ‘one or more processing circuitries’ in claim 21; ‘communication circuitry’ in claim 30; ‘a communication link’ in claims 21, 30, 31, and 40; ‘an external computing device’ in claims 21, 31, and 40; ‘an insertable cardiac monitor’ in claims 29 and 39, ‘a non-transitory computer-readable storage medium’ in claim 40, ‘processing circuitry’ in claim 40, ‘accelerometer circuitry configured to generate at least one signal’ in claim 40
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose each of the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b). In this instance the accelerometer circuitry is merely used in a data gathering step. Further the implantable medical device aspect merely indicates field-of-use.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 22-28 and 32-38 are steps that are also abstract as a mental process through additional data gathering or analysis
Claims 29 and 39 recites additional elements that merely indicate field of use
Claims 30 recites additional elements which are claimed a high level of generality and which are conventional in the art
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11717186.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application 18/339,719
Conflicting US Patent No. 11717186
21. An implantable medical device configured to be implanted in a patient comprising:
one or more accelerometer circuitries configured to generate at least one signal;
one or more memories; and
one or more processing circuitries coupled to the accelerometer circuitry, and the memory, the processing circuitry configured to:
detect, based upon the at least one signal, a Sit-to-Stand transition of the patient in which the implantable medical device is implanted;
determine, based on the at least one signal, that the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition;
based on the determination that the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one signal by determining at least one of a) a first step taken by the patient after the Sit-to- Stand transition based on the at least one signal, b) a peak or valley in the at least one signal, c) an amplitude of a peak to a valley in the at least one signal, d) a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) a slope of the at least one signal; and
transmit, via a communication link and to an external computing device, data that is usable by the external computing device to generate an output that is based at least in part on a likelihood the patient may fall.
1. An implantable medical device configured to be implanted in a patient comprising:
accelerometer circuitry configured to generate at least one signal;
communication circuitry configured to establish a communication link with an external computing device;
a memory; and
processing circuitry coupled to the accelerometer circuitry, the communication circuitry, and the memory configured to:
detect a Sit-to-Stand transition of the patient in which the implantable medical device is implanted based upon the at least one signal;
determine if the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition based on the at least one signal;
if the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one signal by at least one of a) determining a first step taken by the patient after the Sit-to-Stand transition based on the at least one signal and determining a length of time from the Sit-to-Stand transition to the first step taken by the patient, b) determining a count of at least one of a number of peaks or valleys in the at least one signal during a predetermined time period associated with the Sit-to-Stand transition, c) determining an amplitude of a peak to a valley in the at least one signal, d) determining a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) determining a slope of the at least one signal;
determine a body stability score of the patient based on the processing of the at least one signal, the body stability score being indicative of a likelihood the patient may fall; and send the body stability score from the communication circuitry to the external computing device via the communication link to track health of the patient over time.
31. A method of operating an implantable medical device configured to be implanted in a patient, the method comprising:
detecting, based upon at least one accelerometer signal, a Sit-to-Stand transition of the patient in which the implantable medical device is implanted;
determining, based on the at least one accelerometer signal, that the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition;
based on the determination that the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one accelerometer signal by determining at least one of a) a first step taken by the patient after the Sit-to-Stand transition based on the at least one accelerometer signal, b) a peak or valley in the at least one accelerometer signal, c) an amplitude of a peak to a valley in the at least one accelerometer signal, d) a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one accelerometer signal, or e) a slope of the at least one accelerometer signal; and
transmit, via a communication link and to an external computing device, data that is usable by the external computing device to generate an output that is based at least in part on a likelihood the patient may fall.
11. A method comprising:
detecting, by processing circuitry of an implantable medical device configured to be implanted in a patient, a Sit-to-Stand transition of the patient in which the implantable medical device is implanted based on at least one accelerometer signal;
determining, by the processing circuitry, if the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition based on the at least one signal;
if the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand, processing, by the processing circuitry, the at least one signal by at least one of a) determining a first step taken by the patient after the Sit-to-Stand transition based on the at least one signal and determining a length of time from the Sit-to-Stand transition to the first step taken by the patient, b) determining a count of at least one of a number of peaks or valleys in the at least one signal during a predetermined time period associated with the Sit-to-Stand transition, c) determining an amplitude of a peak to a valley in the at least one signal, d) determining a measure of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) determining a slope of the at least one signal;
determining, by the processing circuitry, a body stability score of the patient based on the processing of the at least one accelerometer signal, the body stability score being indicative of a likelihood the patient may fall; and sending, by communication circuitry of the implantable medical device, the body stability score to an external device via the communication link to track health of the patient over time.
40. A non-transitory computer-readable storage medium comprising instructions, that when executed by processing circuitry of an implantable medical device comprising accelerometer circuitry configured to generate at least one signal, cause the device to:
detect, based upon the at least one signal, a Sit-to-Stand transition of a patient in which the implantable medical device is implanted;
determine, based on the at least one signal, that the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition;
based on the determination that the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one signal by determining at least one of a) a first step taken by the patient after the Sit-to-Stand transition based on the at least one signal, b) a peak or valley in the at least one signal, c) an amplitude of a peak to a valley in the at least one signal, d) a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) a slope of the at least one signal; and
transmit, via a communication link and to an external computing device, data that is usable by the external computing device to generate an output that is based at least in part on a likelihood the patient may fall.
20. A non-transitory computer-readable storage medium comprising instructions, that when executed by processing circuitry of an implantable medical device configured to be implanted in a patient, cause the implantable medical device to:
detect a Sit-to-Stand transition of the patient in which the implantable medical device is implanted based upon at least one accelerometer signal;
determine if the patient has been inactive for a predetermined period of time prior to the Sit-to-Stand transition based on the at least one signal;
if the patient has been inactive for at least the predetermined period of time prior to the Sit-to-Stand transition, process the at least one signal by at least one of a) determining a first step taken by the patient after the Sit-to-Stand transition based on the at least one signal and determining a length of time from the Sit-to-Stand transition to the first step taken by the patient, b) determining a count of at least one of a number of peaks or valleys in the at least one signal during a predetermined time period associated with the Sit-to-Stand transition, c) determining an amplitude of a peak to a valley in the at least one signal, d) determining a length of time for the amplitude of the peak to the valley to reach a predetermined amplitude threshold in the at least one signal, or e) determining a slope of the at least one signal;
determine a body stability score of the patient based upon the processing of the at least one accelerometer signal, the body stability score being indicative of a likelihood the patient may fall; and send the body stability score from communication circuitry to an external device via a communication link to track health of the patient over time.
For claims 21-39: The difference between the rejected claims of the instant application and patented claims of the patent lies in the fact that the patented claims are more specific (i.e. the patent claiming more specifically a body stability score for tracking a user over time as opposed to merely data/output in the instant application) Thus, the invention of patented claims is in effect a “species” of the “generic” invention of rejected claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since rejected claims are anticipated by patented claims, it is not patentably distinct from patented claims.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11717186 in view of Zhang et al. (US 2015/0302720). The only difference between claim 40 of the instant application and claim 20 of the patent is the inclusion of accelerometer circuitry which is conventional equipment in the art and is taught by at least Zhang (element 8; Paragraph 0039) and it would have been obvious to one of ordinary skill in the art to have modified the patent with Zhang because it would be using conventional known in the art equipment to identify when a user has transitioned from a sitting posture to a standing posture and vice versa from measurements of the movement of the user. Identifying these posture changes allows an estimation of the time-on-leg for the user. The time-on-leg can be the sum of all time periods when the user is determined not to be sitting or lying down, e.g. following a transition from a sitting posture to a standing posture until the next transition from a standing posture to a sitting posture (Paragraph 0007 of Zhang).
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 PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JASON SIMS can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
Prosecution Insights