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 53 is objected to because of the following informalities: the claim recites BLUETOOTH, this should read BLUETOOTH®. 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 45 is 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 45 recites “the primary processor executes a first kernel and the secondary processor executes a second kernel”. The only mention of a kernel is in paragraph 0139 of applicants disclosure (US 2025/0058134). In paragraph 0139 it states “In some implementations, the components of the medical device controller 120 may protect the primary operations of the controller 120 by executing a single operating system with two or more kernels (e.g., Xenomai operating system extension). In this implementation, the primary operations are serviced by a first kernel that executes one or more patient care components and the limited functionality operations are serviced by a second kernel that executes a limited functionality component (e.g., the limited functionality component 330). Further, in this implementation, the first kernel is executed with greater priority than the second kernel. In this way, the primary operations are isolated from and not affected by the limited functionality operations.” This recitation indicates that the use of kernels is only for a singular controller executing a single operating system with two or more kernels. This does not teach or disclose a primary and secondary processor. Therefore because the claim language, in claim 45, is not supported by the specification and/or contradicts the specification the specification fails to disclose claim 45. No prior art will be used regarding claim 45 because the language is not supported. Claim 15 is rejected under 35 U.S.C § 112 and it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)).
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 49 is 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 49: the claim recites “wherein the predetermined pattern comprises a predetermined upward trend”. It is unclear what a predetermined upward trend is in reference to. This language is therefore indefinite.
Claim Rejections - 35 USC § 102
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 42-44, 46-47, 51-53 and 60-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al. US 2014/0277227.
Regarding claim 42: Peterson discloses a medical device 401 (figures 4-6) for monitoring parameters (“electrical activity of the heart”, paragraph 0077) of a patient, the medical device comprising;
memory 524/672 (figures 5-6);
a plurality of electrodes 406 (figure 4) which can be used to acquire an ECG from the patient (paragraph 0047, 0062-63)
a plurality of processors 422/462 (“defibrillator processor” and “data processor” respectively in figures 5-6) coupled with the memory and the electrodes, the plurality of processors comprises a primary processor 422 (paragraph 0074 defibrillator processor 422 is the master, figure 5) and a secondary processor 462 (paragraph 0074 data processor 462 is the slave, figure 6)
the primary processor 422 (figure 5) executes primary operations of the medical device (paragraph 0076) with a primary operation including monitoring a heart rate (as is seen in figure 7 the defibrillation processor module 420 is considered to be the Main CPU and receives sensed signals 731 which are ECG signals and would necessarily include heart rate) and;
the secondary processor 460 (figures 6-7) which executes a limited functionality operation 743/748 (Video and Data Streams/Controls of tools, figure 7) which is isolated from the primary operations (as is shown in figure 7 only the communication CPU/Data processor 462 sends the commands for Video and Data Streams and Controls of tools), this is considered to protect the primary operation of defibrillation and sensing performed by the Main CPU 420.
Regarding claim 43: Peterson discloses a primary data store 524 (figure 5) and a secondary data store 672 (figure 6); with the primary data store 524 (figure 5) comprises data related to a primary operation (paragraphs 0099-0100) and the secondary data store comprises data for the limitational functionality (paragraph 0074).
Regarding claim 44: Peterson discloses that the primary processor is a first core and the secondary processor is a second core of a multicore processor (paragraph 0087).
Regarding claim 46: Petersen discloses that the medical device comprises a network interface 680 (figure 8, paragraph 0083) and the one or more limited functionality operations (in figure 7, 711 is a display screen showing heart rate and other parameters which are considered to be the limited functionality) comprises communicating the patient’s heart rate to another device via the network interface (communication occurs via communication link 416 within the data processor module 460 to an external utility 415 such as a patient monitor or computing device (see paragraph 0083), figure 8).
Regarding claim 47: Petersen discloses communicating heart rate (see 711 of figure 7, heart rate is shown), this is a display on a separate device (paragraph 0088). This is considered to be communicating the patient’s heart rate to another device, this heart rate is communicated regardless and would be communicated if a threshold is crossed. The language “if the patient’s heart rate exceeds a threshold value” is considered to be optional language, heart rate is shown to be communicated to another device which meets the language.
Regarding claim 51: Petersen discloses that the other device is a remote server (“server”, paragraph 0083) or a communication device (“mobile computing device”, paragraph 0083).
Regarding claim 52: Petersen discloses that the other device is a communication device (“mobile computing device”, paragraph 0083) and the medical device is in communication with the device 781 (figure 7) which is considered to be “paired”.
Regarding claim 53: Petersen disclose Bluetooth® (paragraph 0084).
Regarding claim 60: Petersen discloses monitoring for arrhythmia (paragraphs 0005-0006, 0033, 00470-41).
Regarding claim 61: Petersen discloses the claimed invention including a plurality of electrodes 406 (figure 5) which are coupled to the defibrillator processor 422 (figure 5) which is considered to be a primary processor, and defibrillating the patient if ventricular fibrillation occurs (paragraphs 0007-0008, 0034, 0037).
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.
Claims 48-50 and 54-59 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. US 2014/0277227 in view of Krusor et al. US 2014/0049377.
Regarding claim 54: Peterson discloses the claimed invention including a network interface 680 (figure 8) and sending data to an external device 710 (figure 7, paragraph 0088). However, Peterson does not disclose determining if an electrode is not properly attached and sending an alert. Krusor however teaches of a defibrillator 888 (figure 8) which detects if an electrode is coming off the skin and sending an alert (paragraph 0096-98). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Petersen to include determining when an electrode has detached and sending an alert, as taught by Krusor, in order to alert the patient to avoid improper sensing or defibrillation.
Regarding claim 55: Peterson discloses the claimed invention including a network interface 680 (figure 8) and sending data to an external device 710 (figure 7, paragraph 0088). However, Petersen does not specifically disclose sending an alert. . Krusor however teaches of a defibrillator 888 (figure 8) which can send an alert to a patient (paragraph 0096-98). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Petersen to include sending an alert to a patient, as taught by Krusor, in order to alert the patient of specific situations. Regarding the claim language if elapsed time since compliance with a treatment schedule has exceeded a day is considered to be intended use. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises a network interface which is capable of sending an alert combined with the alert of Krusor.
Regarding claims 48-50 and 56-59: the claims are considered to recite functional and/or intended use language. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises a network interface which is capable of sending an alert combined with the alert of Krusor.
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 42 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5 of U.S. Patent No. 12,168,139. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
18/938,575
12,168,139
Claim 42:
A medical device for monitoring parameters of a patient, the medical device comprising: memory; a plurality of sensing electrodes configured to acquire cardiac signals indicative of cardiac activity of the patient; and a plurality of processors coupled with the memory and the plurality of sensing electrodes, the plurality of processors comprising a primary processor and a secondary processor, the primary processor being configured to execute one or more primary operations of the medical device, the one or more primary operations comprising monitoring a heart rate of the patient, and the secondary processor being configured to execute one or more limited functionality operations isolated from the one or more primary operations, thereby protecting the one or more primary operations from being affected by the one or more limited functionality operations.
Claim 1.
An ambulatory medical device for providing patient care, the ambulatory medical device comprising: a power supply configured to provide power to the ambulatory medical device; memory configured to provide a primary data store and a secondary data store; at least one sensing electrode configured to acquire electrocardiogram (ECG) signals from a patient; at least one treatment electrode coupled with the power supply and configured to provide a defibrillating shock to the patient; one or more processors coupled to the power supply, the memory, the at one least sensing electrode, and the at least one treatment electrode and configured to convert the ECG signals into ECG data; a patient care component executable by the one or more processors and configured to perform one or more primary operations of the ambulatory medical device at least in part by being configured to store primary data based on the ECG data in the primary data store, and store secondary data based on the ECG data in the secondary data store; and a limited functionality component executable by the one or more processors and configured to not affect the one or more primary operations of the ambulatory medical device at least in part by being configured to manipulate data stored in the secondary data store, wherein the limited functionality component is configured to either no access or read-only access of data stored in the primary data store.
Claim 3.
The ambulatory medical device of claim 1, wherein: the one or more processors comprise a primary processor and a secondary processor; the patient care component is executable by the primary processor; and the limited functionality component is executable by the secondary processor.
Claim 45.
The medical device of claim 42, wherein: the primary processor executes a first kernel; and the secondary processor executes a second kernel.
Claim 5.
The ambulatory medical device of claim 1, wherein: the one or more processors are further configured to execute a plurality of kernels comprising a first kernel and a second kernel; the patient care component is executable via the first kernel; and the limited functionality component is executable the second kernel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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