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
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-3, 5, 9, 10 and 26-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation in claim 1, “body worn and/or implanted medical device”, and in claim 26, “an implanted and/or body worn component” require the device and component, respectively, be physically attached to the body, and therefore are considered to claim the human body.
It is recommended Applicant amend to include functional language. For example: “a medical device configured to be body worn and/or implanted” and “a component configured to be implanted and/or body worn”, respectively.
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.
Claims 1-5, 9-13 and 20-30 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al (US 2017/0113057).
Regarding claim 1, Goodall discloses a system, comprising: a body worn 320 and/or implanted medical device 300, wherein the medical device is configured to receive and store data 1334. Goodall does not specify the stored data is indicative of past treatment of a person who is the wearer and/or has been implanted with the medical device. One of ordinary skill in the art would have found it obvious to store data indicative of past treatment of the person because Goodall teaches memory 1336 contains stored stimulus patterns and neural stimulus parameter values from which neural stimuli can be computed and prediction circuitry 1342 predicts a future neural activity signal based on a previous neural activity signal, see paragraph [0149]. Without undue experimentation and based on the suggestion in Goodall to use previous neural activity, the skilled artisan would have been motivated to store data indicative of past treatment of a person who is the wearer and/or has been implanted with the medical device and to configure the medical device to at least one of provide tissue stimulation 312 to tissue of the person or sense phenomenon associated with the person, see paragraph [0193].
Regarding claim 2, Goodall discloses: the medical device 300 is a first subsystem of the system; the system includes a second subsystem, a personal computing device 208; the medical device 300 is configured to electronically communicate data indicative of the stored data to the second subsystem; and the second subsystem is configured to receive the communicated data and at least one of provide the data in a human understandable format or analyze the data and develop at least a partial treatment regimen based on the analysis, see paragraph [0101].
Regarding claim 3, Goodall discloses: the second subsystem is configured to analyze the data and develop at least a partial treatment based on the recipient; the second subsystem is configured using a personal account 1510 to communicate the developed at least partial treatment to the medical device 300; and the medical device is configured to receive the communicated developed at least partial treatment and operate in a different manner based on the received communicated developed at least partial treatment, see paragraph [0471].
Regarding claim 5, Goodall discloses: the medical device is an implantable hearing prosthesis, see paragraphs [0095] and [0101].
Regarding claim 9, Goodall discloses: the neural stimulation system 700 includes a clock or timer 816 and producing a stimulus 708 based on a time of day or date, see paragraph [0114]. One of ordinary skill in the art would have found it obvious to configure the medical device 300 to have stored therein data indicative of therapeutic substance(s) taken by the person within at least the past 10 days for the drug delivery device 844, see paragraph [0116].
Regarding claim 10, Goodall discloses recommendation 1372 relates to a user experience, see paragraph [0154]. Complying with a treatment is a user experience one of ordinary skill in the art would have found desirable for the medical device 300 to be configured to identify biomarkers of the person and determine a compliance of past treatment.
Regarding claim 11, Goodall discloses a method:
receiving, indirectly or directly, from a body worn 320 and/or implanted medical device 300. Data is received from 320 and 300 and stored in memory 1334. Goodall does not specify the data is indicative of at least one of a treatment history or a current medical condition of a person wearing and/or implanted with the medical device 300. One of ordinary skill in the art would have found it obvious to store data indicative of a treatment history or a current medical condition of the person because Goodall teaches memory 1336 contains stored stimulus patterns and neural stimulus parameter values from which neural stimuli can be computed and prediction circuitry 1342 predicts a future neural activity signal based on a previous neural activity signal, see paragraph [0149]. Without undue experimentation and based on the suggestion in Goodall to use previous neural activity, the skilled artisan would have been motivated to use data indicative of at least one of a treatment history or a current medical condition of a person wearing and/or implanted with the medical device 300 for evaluating at least the data and determining, based on the evaluation, a treatment regimen for the person; and implementing the treatment regimen or providing the treatment regimen to the person, see paragraph [0193].
Regarding claim 12, Goodall discloses: the body worn 320 and/or implanted medical device 300 is configured to sense a physiological phenomenon of the person, see paragraph [0161]. It is inherent at least prior to the action of receiving, stored data indicative of the treatment history of the person enables determination circuitry 1308 to determine the person is completely conscious; and the action of evaluating is executed without real time input from the person regarding the treatment history, see paragraph [0161].
Regarding claim 13, Goodall discloses: the body worn 320 and/or implanted medical device 300 is configured to sense a physiological phenomenon of the person, see paragraph [0161]. Goodall teaches using artificial intelligence to generate recommendations, see paragraph [0193]. One of ordinary skill in the art would have found it obvious to at least prior to the action of receiving, to configure the body worn 320 and/or implanted medical device 300 to have stored therein the data indicative of the treatment history of the person; and based on the teaching to use artificial intelligence for determining a recommendation, to execute the action of evaluating and determining automatically using artificial logic.
Regarding claim 20, Goodall discloses: the medical device 300 is a hearing prosthesis 4031; the hearing prosthesis was used in conjunction with the person to evaluate the person's hearing, see paragraph [0261]. The data is indicative of a current medical condition, wherein the current medical condition is the person's ability to hear, and the data is based on data obtained when using the hearing prosthesis to evaluate the person's hearing.
Regarding claim 21, Goodall discloses: the treatment regimen is the adjustment and/or the addition of a therapeutic substance to treat hearing disorder related ailments, see paragraph [0113].
Regarding claim 22, Goodall discloses controlling an ear stimulation device based on personal interaction with a computing device, see paragraph [0032]. One of ordinary skill in the art would have found it obvious and desirable to decrease drug dosage for a person taking a therapeutic substance to treat an ailment for at least a month prior to the action of determining; and the action of evaluating and determining results in a treatment regimen for the person that results in a decrease in an average daily amount of the therapeutic substance during the time of implementing the treatment regimen.
Regarding claim 23, Goodall discloses: the body worn 320 and/or implanted medical device 300 is configured to sense a physiological phenomenon of the person, see paragraph [0161]. Goodall further discloses implementing the treatment regimen automatically; the person has a therapeutic substance delivery system attached thereto; the action of implementing the treatment regimen automatically causes the therapeutic substance delivery system to automatically provide a fast acting therapeutic substance in a quantity and/or quality automatically determined in the action of determining the treatment regime, see paragraph [0116]. One of ordinary skill in the art would have found it obvious for at least two weeks prior to the action of implementing the treatment regimen, the person has been receiving therapeutic substance in amounts and/or types substantially different from that provided during the action of automatically providing because Goodall suggests using various types of stimuli to improve outcomes, see paragraph [0186].
Regarding claim 24, Goodall discloses a signal received at secondary signal input 800 includes a signal from a substance delivery device 802. Goodall does not disclose a closed-loop monitoring and therapeutic substance delivery system, wherein: the closed-loop monitoring and therapeutic substance delivery system is configured to monitor one or more physiological parameters of a user of a medical device 300. However, Goodall suggests using inputs pertaining to the health of a subject to determine a neural stimulation system 700 response, see paragraph [0113].
One of ordinary skill in the art would have found it obvious to use the secondary signal input 800 for a closed-loop monitoring and therapeutic substance delivery device 802 because a therapeutic drug has a physiologic effect pertaining to the health of the subject.
The skilled artisan would have found it desirable and without undue experimentation to configure the closed-loop monitoring and therapeutic substance delivery system to use results from the monitored one or more physiological parameters to establish a dosage and/or schedule for future therapeutic substance(s) to be taken by and/or administered to the user, see paragraphs {0113], [0116] and {0193].
Regarding claim 25, Goodall discloses: the system is further configured to have access to data indicative of therapeutic substance(s) previously used and/or currently used by the user, see paragraph [0116]. One of ordinary skill in the art would have found it obvious based on providing a safe and effective dosage to configure the closed-loop monitoring and therapeutic substance delivery system to use results from the monitored one or more physiological parameters in conjunction with the data indicative of therapeutic substance(s) to establish the dosage and/or schedule for future therapeutic substance(s) to be taken by and/or administered to the user, see paragraph [0116].
Regarding claim 26, Goodall discloses: the system includes an implanted and/or body worn component that monitors the one or more physiological parameters; and the system further includes a therapeutic substance delivery device to deliver the future therapeutic substance(s), see paragraph [0116}.
Regarding claim 27, Goodall discloses: the system includes a first subsystem 300, the first subsystem being configured to execute the monitoring and obtaining of the data; and the delivery device is in signal communication with the first subsystem and/or another subsystem, a personal computing device 208, in signal communication with the first subsystem. One of ordinary skill in the art would have found it obvious to configure the delivery to receive data based at least in part on data based on the dosage and/or schedule and operate accordingly to deliver the future therapeutic substance(s) to the recipient.
Regarding claim 28, Goodall discloses a substance delivery device 802. One of ordinary skill in the art would have found it obvious to configure the delivery device 802 to operate accordingly to deliver the therapeutic substance(s) according to the dosage and/or schedule only if the recipient approves the operation using personal computing device 208 to ensure compliance with the dosage and treatment protocols.
Regarding claim 29, Goodall discloses the system includes a first subsystem 300, the first subsystem being configured to execute the monitoring and obtaining of the data; and at least the first subsystem or a second subsystem, a personal computing device 208 that is a part of the system and is in signal communication with the first subsystem. One of ordinary skill in the art would have found it obvious, based on recommended dosing, to configure the computing device 208 to provide output indicative of the dosage and/or schedule; and to configure the delivery device 802 to enable manual initiation of dispensement of the therapeutic substance based on the output.
Regarding claim 30, Goodall discloses: the system includes a monitoring device 208 configured to monitor the one or more physiological parameters; and the system includes a therapeutic substance delivery device 802 configured to deliver therapeutic substance to the user, the therapeutic substance delivery device 802 being a physically separate device from the monitoring device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Heldman et al (US 9,211,417) disclose a related patient monitoring and treatment system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
The examiner can normally be reached on regular business days.
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, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/George Manuel/
Primary Examiner
Art Unit: 3792
1/15/2026