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.
Claims 11, 13, 16-19, 21, 24, 26, 28, 31, 33, and 36-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept of obtaining an input, selectively perform a verification process, and bypass the verification process. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. claim 11—a processor; claim 21—a stimulator, sensor, and a processor; claim 26—a computer readable medium; claim 31—not connected to any element; and dependent claims use of a first sensor, second sensor, medical device, control device, and/or implantable housing, etc.) fails to integrate the judicial exception into a practical application. The generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, the use of a first sensor, second sensor, medical device, control device, and/or implantable housing are insignificant extra-solution activity and do not add a meaningful limitation as they are merely a nominal or token extra-solution component of the claim and are nothing more than an attempt to generally link the product to a particular technological environment, and/or are meant to gather data for the abstract idea, delivery generic stimulation to the patient, or house the components. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. The additional limitations only store and retrieve information from memory, or perform different processes, and these limitations are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of obtaining an input, selectively perform a verification process, and bypass the verification process, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. claim 11—a processor; claim 21—a stimulator, sensor, and a processor; claim 26—a computer readable medium; claim 31—not connected to any element; and dependent claims use of a first sensor, second sensor, medical device, control device, and/or implantable housing, etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the use of a first sensor, second sensor, medical device, control device, and/or implantable housing are insignificant extra-solution activity and do not add a meaningful limitation as they are merely a nominal or token extra-solution component of the claim and are nothing more than an attempt to generally link the product to a particular technological environment, and/or are meant to gather data for the abstract idea, delivery generic stimulation to the patient, or house the components. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 11 having a processor, claim 21, a stimulator, sensor and processor, claim 26, a memory, and corresponding method claim 31, not connected to any element) is a system having a memory and processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the command input information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The memory and processor are recited so generically (no details whatsoever are provided other than that they are a memory and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. In addition, the use of a first sensor, second sensor, medical device, control device, and/or implantable housing are insignificant extra-solution activity and do not add a meaningful limitation as they are merely a nominal or token extra-solution component of the claim and are nothing more than an attempt to generally link the product to a particular technological environment, and/or are meant to gather data for the abstract idea, delivery generic stimulation to the patient, or house the components. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and the memory. No element has been set forth to sense the command input signal, and the only additional element is the memory, where the processor performs the necessary software tasks so that the result of the abstract mental process is just performing or not performing a verification process. In addition, the use of a first sensor, second sensor, medical device, control device, and/or implantable housing are insignificant extra-solution activity and do not add a meaningful limitation as they are merely a nominal or token extra-solution component of the claim and are nothing more than an attempt to generally link the product to a particular technological environment, and/or are meant to gather data for the abstract idea, delivery generic stimulation to the patient, or house the components. The memory limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of obtaining an input, selectively perform a verification process, and bypass the verification process, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Claims 26 and 28 are rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention and thus fails as eligible subject matter. Claim 26 characterizes the invention as a “computer-readable medium having instructions”. A broadest reasonable interpretation of this language typically covers forms of non-transitory tangible media and transitory propagating signals per se, which are not patentable under 35 U.S.C. 101. Claims that cover both statutory and non-statutory embodiments under the broadest reasonable interpretation of the claims when read in light of the specification and in view of one skilled in the art, embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The claim is considered to be broad enough to cover a transitory propagating signal that carries a programmed instruction set. Furthermore, even when the claim is directed to one of the four statutory categories of invention, the claim must not be wholly directed to subject matter encompassing a judicially recognized exception without a particular practical application. In the instant case, in addition to failing to fall within one of the four statutory categories of invention, the claim recites only instructions, i.e. an algorithm that is not limited to a particular practical application.
It is suggested to add “non-transitory” to the claim.
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 11, 13, 16-19, 21, 24, 26, 28, 31, 33, and 36-41 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.
In claim 11, “selectively perform a verification process…and bypass the verification process” is vague and conflicts. It is unclear what happens if the system selectively performs the verification process. How then does the system bypass the process? It is unclear what functions are being set forth in the claim. In line 5, “prior to controlling the medical device” is vague and unclear if the system is setting forth that the medical device is actually being controlled. Or, if the claim is just positively reciting/claiming the performing of the verification process without any control of the medical device. In the next to last line “responsive to detecting an occurrence of one or more scenarios” is vague and inferentially included. It is unclear if the system is positively reciting/claiming the detecting of the occurrence, or if it is meant as an intended use/functional limitation. In order for the bypass to be “responsive to detecting” the claim should first set forth that the detecting is being performed. Otherwise, the bypass only needs to receive some sort of data (e.g. a binary “1” or “0”) to bypass the verification since it would be an intended use not actually requiring a detection of the occurrence.
A suggested clam format would be
“…obtain input defining a command for control of a medical device;
determine whether one or more scenarios occur;
responsive to determining the scenario did not occur, performing a verification process and then controlling the medical device based on the input and verification process; and
responsive to determining the scenario did occur, bypass the verification process and controlling the medical device based on the input.
Similarly, claims 21, 26 and 31 contain comparable language and are vague.
In claim 17, “responsive to detecting the occurrence…” is vague and inferentially included and it is unclear if the system is positively reciting/claiming the detecting or the limitation is meant as an intended use/functional limitation. As the process is “responsive” to the detecting, the system should first set forth some element to perform the detecting for the process to be responsive to it.
Similarly, claim 37 has this problem.
In claim 18, “responsive to the input failing the verification process” is vague and lacks antecedent basis. No step has been set forth to have the verification process act on the input.
Similarly, claim 38 has this problem.
In claim 21, “a sensor” makes the claim vague and incomplete for omitting structural cooperative relationship between elements for not connecting the sensor to any other element in the system. The claim is just a listing of parts.
In claim 36, “based on data obtained from a second sensor” is vague and unclear if the method is setting forth obtaining data from a second sensor. Method steps should use active voice to positively recite/claim a method step. In addition, if the step is “based on” the data obtained from the sensor, the claim should first set forth a step to obtain the data.
In claim 39, “wherein bypassing the verification…detecting…includes: determining that a false positive…threshold” is vague as it is unclear whether the “determining…” is part of the bypassing the verification process, or if it is part of the detecting an occurrence. It is unclear how the “determining…” operates with lines 1 and 2 of the claim.
Similarly, claim 40 has this problem and it is unclear if the “determining…” is directed to the “one or more scenarios” or the bypassing.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11, 13, 16, 18, 21, 24, 26, 31, 33, 36, 38, and 40 are rejected under 35 U.S.C. 102a1 as being anticipated by Corndorf (8102999). Corndorf discloses the following claimed elements
-an implantable medical device (e.g. figure 1, col. 22, lines 47-51, etc.; pacemaker, defibrillator, neural stimulator, necessarily having a housing, sensor to detect the external transmission signals, and stimulator —in the alternative, see the 103 rejection below.)
--the system and method using microprocessors and software, necessarily requiring a computer readable medium with instructions (e.g. col. 6, lines 20-45, col. 9, lines 1-20, etc.)
--obtaining/receiving an input command to control the device (e.g. col. 1, lines 25-32 to transmit data or change treatment; col. 9, line 60 to col. 10, line 25 to cause the medical device to prepare and transmit data; col. 22, lines 47-51 to place the device in standby)
--selectively perform a verification based on the input (e.g. col. 10, lines 25-27, etc. of verifying the input command data to authorize the external device) and not allowing the medical device to transfer data if the verification/authentication fails (claim 18, etc.).
--bypasses verification based on a detection of a scenario (e.g. cols. 22-23, putting the device in backdoor mode so no authentication is required—col. 22, lines 65-66, etc.). This meets the claimed “consistent context scenario” or current context as the command is compared with a context in which the medical device is operating and will consistently bypass verification when in the backdoor mode. A command to open the backdoor to sense for a magnetic signal is compared with the context the medical device is operating in—whether a magnet is next to the medical device (e.g. col 23, lines 34-49, etc.)—to allow for the backdoor to open.
--for claim 16, the first sensor is to detect Bob initiating a “deliver BAN key” (e.g. col. 9, lines 65-66, etc.), a second sensor to obtain the data from the first sensor (e.g. col. 9, line 65 to col. 10, line 1, etc.).
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 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Corndorf. In the alternative for claims 21 and 24, Corndorf discloses the use of an implantable device for pacing, defibrillating, or neural stimulation, and a sensor to detect the backdoor signal or external transmission signals, and shows elements in a housing (figure 1, etc.), but does not specifically disclose a sensor, stimulator for providing the pacing/defibrillation/stimulation, and the processor in an implantable biocompatible housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Corndorf, with the use of a sensor, stimulator for providing the pacing/defibrillation/stimulation, and the processor in an implantable biocompatible housing, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing all the components of the system to be implanted in one unit in the body to allow for automatic detection and delivery of therapy in a unit that is biocompatible with the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 12/17/25