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 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 1-4 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). Specifically, the claiming of structures being in contact with or implanted within the body amounts to an inferential recitation of the body, which renders these claims non-statutory. Claim 1 recites “an implantable medical device implanted into a body to stimulate a specific area in the body” in lines 2-3. The examiner recommends changing “implanted into” to –configured to be implanted into--.
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 3-4 and 6 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.
Claims 3 and 4 recite “the management terminal performs a basic test on a condition of a patient by using vital sign information including a blood pressure, a body temperature, and a heart rate in the received patient condition information, and controls to adjust the stimulation applied to the specific area in the body when the condition of the patient is normal as a test result”. However, this appears to be in direct conflict with the limitations recited in claim 1 , which states “the management server analyzes all parameters included in the patient condition information, changes a scheme of controlling the stimulation applied to the specific area in the body based on an analysis result, and changes a scheme of controlling the stimulation applied to the specific area in the body according to the analysis result” and “provides the selected stimulation control scheme to the management terminal”.
It is unclear if the management terminal, as recited in claims 3 and 4, also performs the same functions as the management server (as recited in claim 1). Further clarification is requested.
Claim 6 recites “performing, by the management terminal, a basic test on a condition of the patient by using vital sign information including a blood pressure, a body temperature, and a heart rate in the patient condition information”. However, this appears to be in direct conflict with the limitations recited in claim 5, which states “continuously receiving, by the management server, the patient condition information from the management terminal, analyzing the received patient condition information, disease information, and treatment information, and changing the stimulation control scheme, wherein in the step (d), the management server analyzes all parameters included in the patient condition information, and changes a scheme of controlling the stimulation applied to the specific area in the body based on an analysis result, and changes a scheme of controlling the stimulation applied to the specific area in the body according to the analysis result, predicts a treatment effect by performing a simulation according to the changed scheme to select a stimulation control scheme, and provides the selected stimulation control scheme to the management terminal”.
It is unclear if the management terminal, as recited in claim 6, also performs the same functions as the management server (as recited in claim 5). Further clarification is requested.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osorio et al. (US 2004/0138516 A1).
As to claim 1, Osorio et al. discloses an implantable medical device (Figures 9 and 12-14) implanted into a body to stimulate a specific area in the body ([0042]; Figures 9 and 12-14); a management terminal (relaying module, depicted as 1415 in Figure 14; [0075]) configured to control driving of the implantable medical device by communicating with the implantable medical device through a wireless communication scheme ([0075]; Figure 14); and a management server (external programmer, depicted as 23 in Figure 12 and 1425 in Figure 14; [0046, 0065, 0069, 0192-0193]) configured to communicate with the management terminal (Figure 14), analyzes condition information of a patient corresponding to each parameter for treating a disease of the patient ([0040, 0193, 0196]), and provides analyzed information to the management terminal (Figure 14), wherein the management server analyzes all parameters included in the patient condition information ([0069, 0103, 0196]), changes a scheme of controlling the stimulation applied to the specific area in the body based on an analysis result ([0193, 0196-0198]), and changes a scheme of controlling the stimulation applied to the specific area in the body according to the analysis result (repeated limitation, see previous), predicts a treatment effect by performing a simulation according to the changed scheme to select a stimulation control scheme ([0137-0139, 0144, 0153]; Figure 20), and provides the selected stimulation control scheme to the management terminal (Figure 14), and wherein the management terminal controls the implantable medical device to adjust the stimulation according to the stimulation control scheme provided to the management server such that the patient is maintained in a stable state (claims 1, 8, 17, 25; [0137-0139, 0144, 0153]; Figure 14).
As to claim 2, Osorio et al. discloses a power transmitter (antenna for facilitating telemetric communications; Figures 12 and 14) for transmitting power from an outside of the body to the implantable medical device (Figure 12 and 14) in a wireless power transmission scheme ([0192]; rechargeable battery) using an ultrasonic wave (in order to power the rechargeable battery, the power would be transmitted through a “wireless power transmission scheme” to the implantable device); and a patient terminal (physician programmer; depicted as 1435 in Figure 14; [0069, 0071]) for receiving drug information prescribed for the patient through a communication with the management terminal ([0193-0195]; Figure 14), detecting dose information of corresponding drug ([0121]) and the patient condition information ([0121]), and transmitting detected information to the implantable medical device and the management server (Figure 14; [0121]), wherein the management terminal controls the driving of the implantable medical device based on the detected information ([0121, 0135, 0137]) and test information received from the patient terminal and a test equipment that communicates with the management terminal ([0121]; claims 1, 18-19).
As to claim 3, as best understood in light of the rejection under 35 U.S.C above, Osorio et al. discloses management terminal (relaying module; [0075]) performs a basic test on a condition of a patient by using vital sign information including a blood pressure, a body temperature, and a heart rate in the received patient condition information ([0040, 0046, 0121]; the relay module collects data from the signals and relays the condition information. Therefore, the examiner considers the relaying module to perform a “basic test”, or an aggregation of data, on a condition of a patient by using vial sign information), and controls to adjust the stimulation applied to the specific area in the body when the condition of the patient is normal as a test result (claims 1, 8, 17, 25; [0137-0139, 0144, 0153]; Figure 14).
As to claim 4, as best understood in light of the rejection under 35 U.S.C above, Osorio et al. discloses management terminal (relaying module; [0075]) performs a basic test on a condition of a patient by using vital sign information including a blood pressure, a body temperature, and a heart rate in the received patient condition information ([0040, 0046, 0121]; the relay module collects data from the signals and relays the condition information. Therefore, the examiner considers the relaying module to perform a “basic test”, or an aggregation of data, on a condition of a patient by using vial sign information), and controls to adjust the stimulation applied to the specific area in the body when the condition of the patient is normal as a test result (claims 1, 8, 17, 25; [0137-0139, 0144, 0153]; Figure 14).
As to claim 5, Osorio et al. discloses (a) stimulating, by an implantable medical device (Figures 9 and 12-14), a specific area in a body ([0042]; Figures 9 and 12-14) by using power transmitted from an outside of the body in a wireless power transmission scheme ([0192]; rechargeable battery; in order to power the rechargeable battery, the power would be transmitted through a “wireless power transmission scheme”); (b) analyzing, by a management server(external programmer, depicted as 23 in Figure 12 and 1425 in Figure 14; [0046, 0065, 0069, 0192-0193]), condition information of a patient corresponding to each parameter for treating a disease of the patient ([0040, 0193, 0196]); (c) controlling, by a management terminal (relaying module, depicted as 1415 in Figure 14; [0075]), the implantable medical device (Figure 14) to adjust the stimulation applied to the specific area in the body by the implantable medical device based on an analysis result of the management server ([0137-0139, 0144, 0153]; Figures 14 and 20; claims 1, 8, 17, 25) and (d) continuously receiving, by the management server, (Figure 14) the patient condition information from the management terminal ([0040, 0193, 0196]), analyzing the received patient condition information, disease information, and treatment information, and changing the stimulation control scheme ([0137-0139, 0144, 0153]; Figures 14 and 20; claims 1, 8, 17, 25), wherein in the step (d), the management server analyzes all parameters included in the patient condition information([0069, 0103, 0196]), and changes a scheme of controlling the stimulation applied to the specific area in the body based on an analysis result ([0193, 0196-0198]), and changes a scheme of controlling the stimulation applied to the specific area in the body according to the analysis result (repeated limitation, see previous), predicts a treatment effect by performing a simulation according to the changed scheme to select a stimulation control scheme ([0137-0139, 0144, 0153]; Figure 20), and provides the selected stimulation control scheme to the management terminal (Figure 14), and wherein the management terminal controls the implantable medical device to adjust the stimulation according to the stimulation control scheme provided to the management server such that the patient is maintained in a stable state (claims 1, 8, 17, 25; [0137-0139, 0144, 0153]; Figure 14).
As to claim 6, as best understood in light of the rejection under 35 U.S.C above, Osorio et al. discloses management terminal (relaying module; [0075]) performs a basic test on a condition of a patient by using vital sign information including a blood pressure, a body temperature, and a heart rate in the patient condition information ([0040, 0046, 0121]; the relay module collects data from the signals and relays the condition information. Therefore, the examiner considers the relaying module to perform a “basic test”, or an aggregation of data, on a condition of a patient by using vial sign information).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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