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 § 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 7-8, 15, 17, 23-27, and 30 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 7, the claim is vague and more like a method step than a structural limitation. The claim is not directed to anything structurally of the electronics device but more directed to how the electronics device is formed or determined. It is unclear what specific structural limitation is being claimed. In addition, the claim is relative as different people and animals have different skulls and it is unclear how to determine if a prior art system meets the same structural contour of the claimed device.
Claim 8 is vague as the claim is trying to limit a patient’s skull and not the device. It is suggested to put the claim in functional terms of the device, such as “wherein the lower surface has a contour of the calvarium of the patient’s skull”.
In claim 15, “housed within a sealed housing” is vague and inferentially including the housing. It is unclear if the housing is meant to be positively recited/claimed or is meant as a functional/intended use recitation. If the housing is meant to be positively recited, it is suggested to first state the device “further comprises a sealed housing” before it is further used in the claim.
Similarly, in claim 17, “flexible, electronic connectors” are vague and inferentially included.
In claims 23-27, the claims are vague as they are trying to limit the “one other device” which has not been positively recited/claimed, but only functionally recited (e.g. “configured to be placed…one other device”). If the one other device is meant to be positively recited/claimed, it is suggested to first state the system “further comprises” the one other device. Since the device has not been positively recited/claimed, claims 23-27 should limit the one other device in reference to previously positively claimed/recited elements, such as “wherein the at least a portion of the electronics is configured for an electrode as the one other device…”.
In claim 26, “the memory system” and “the processor system” lack antecedent basis.
In claim 27, “the communication system” lacks antecedent basis.
In claim 30, line 5, “a contour of an outer surface of a portion of a patient’s skull” is vague as this phrase was used in line 2 and it is unclear if the phrase in line 5 is the same element from line 2. If they are the same, then “the contour of the outer surface of the portion of the patient’s skull” should be used in line 5.
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, 2, 5, 7-8, 13, 15, 30 and 58 are rejected under 35 U.S.C. 102a1 as being anticipated by Goetz (2019/0214126). Goetz meets the claimed limitations as follows:
--electronics (e.g. paras. 30, 115, etc.)
--a flexible body (e.g. para. 116, etc.) that carries/houses the electronics (e.g. paras. 30, 115, etc.) that has a lower curved surface to match a contour of the patient’s skull and an upper curved surface implanted between the scalp and skull (e.g. paras. 31, 115-116, etc.)
For method claims 30 and 58, and claims 7 and 8, Goetz discloses forming the IMD/electronic device using CT to determine the contour of the patient’s skull (e.g. abstract, paras. 74, 34, figure 3A, calvarium, etc.). For claims 2, 5 and 13, Goetz discloses a thickness of around 3-6 and 7-10 mm (e.g. paras. 115, 117, etc.) with top curved to approximate bottom curve, with tapered perimeter, and thickness not varying more than 10% from an average thickness except at the perimeter (e.g. figure 5b, in the alternative for claim 13, see the 103 rejection below).
Claims 1, 2, 5, 7-11, 13, 15-18, 22-26, 28-29 and 58 are rejected under 35 U.S.C. 102a1 as being anticipated by Wahlstrand et al (2004/0176817). Wahlstrand meets the claimed limitations as follows:
--electronics (e.g. figures 5, 13, flexible, paras. 58, 87, etc.)
--a flexible body (e.g. paras. 67, 44, 50, etc.) that carries/houses the electronics (e.g. figures 3, 6, paras. 67, 44, 50, etc.) that has a lower curved surface to match a contour of the patient’s skull and an upper curved surface implanted between the scalp and skull (e.g. abstract, figure 8A, etc.)
For claims 2, 5, and 13, Wahlstrand discloses a thickness of around 6 mm (e.g. para. 85, etc.) with top curved to approximate bottom curve, with tapered perimeter, and thickness not varying more than 10% from an average thickness except at the perimeter (e.g. figure 8a showing uniform thickness and curved, figure 11b showing uniform thickness; in the alternative for claim 13, see the 103 rejection below). For claims 7 and 8, the claims are directed to how the device is made and not to a structural limitation, and the determination of patentability is based on the product/device itself. As the device of Wahlstrand meets the structure implied by the process (as it is curved and meant to fit a patient’s skull/calvarium as seen in figure 2), the claims are met. For claim(s): 9 of a flexible device to be sufficiently flexible to be folded (e.g. paras. 58, 87, figures 9, 13, where the flexible silicone material and use of flexible interconnects/tether allow the device to be folded, etc.); 10-11 of silicone flexible body (e.g. para. 67, etc.); 15-17 of sealed housing and spaced nodes connected by flexible connectors (e.g. figures 3, 6b, 8A, paras 77, 78, etc.); 18 of processor, memory, communication, sensor, and power (e.g. figure 5, paras. 62, 54-55, etc.); 22-26, note that the claims do not positively recite/claim the sensors or other implanted device but only that the claimed system (or prior art system) must be capable of meeting the intended use recitations of working/connecting with at least one other device. As Wahlstrand does use electrodes for therapy and sensors for closed loop feedback to work with the processor and memory, and has telemetry to communicate with other devices, Wahlstrand is capable of meeting the functional/intended use limitations of being wirelessly connected to an electrode or sensor to processor sensor signals, such as neural signals, using software in the memory; and 28-29 of pharmaceutical delivery system in communication with the electronics (e.g. paras. 56, 62, 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 19-21 and 27, and in the alternative claim 13, are rejected under 35 U.S.C. 103 as being unpatentable over Wahlstrand et al. Wahlstrand discloses the claimed invention and the use of sensors/monitors to monitor the patient at the location of the IMD (e.g. para. 55, etc.) and the use of telemetry to transmit information to another device, but does not disclose the use of sensors within the flexible body (e.g. claim 19), sensors on the upper and lower surfaces of the device (e.g. claim 20), the sensors being EEG sensors (e.g. claim 21), and the processing sensors signals being transmitted to a remote device to perform a defined action (claim 27). And in the alternative for claim 13, the device not varying more than 10% from an average thickness over the portion of the device. 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 Wahlstrand, with sensors within the flexible body, sensors on the upper and lower surfaces of the device, the sensors being an array of EEG sensors, the processing sensors signals being transmitted to a remote device to perform a defined action, and the device not varying more than 10% from an average thickness over the portion of the device, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of: providing the sensor(s) in the housing so that leads do not need to be tunneled through the patient; providing the sensors on the housing so that leads do not need to be tunneled through the patient and so that the system can sense multiple sensing vectors and areas of the brain; sensing brain neural signals to be used in closed loop feedback system to determine when to apply the brain stimulation; allowing a physician to receive the sensed processed signals to determine if further therapy or action is necessary; and providing a substantially uniform sized housing to provide a smooth surface to prevent bumps or tissue damage.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wahlstrand et al in view of Goetz. Wahlstrand discloses the claimed invention an use on the skull but does not disclose determining a contour of an outer surface of a patient’s skull in order to form the cranial device. Goetz teaches it is known to use CT to form a cranial device so that it can comfortably fit under the patient’s scalp. 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 Wahlstrand, with determining a contour of an outer surface of a patient’s skull, as taught by Goetz, since it would provide the predictable results of forming the cranial device so that it can comfortably fit under the patient’s scalp.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Goetz. Goetz discloses the claimed invention but not specifically the device not varying more than 10% from an average thickness over the portion of the device. 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 Goetz, with the device not varying more than 10% from an average thickness over the portion of the device, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of: providing a substantially uniform sized housing to provide a smooth surface to prevent bumps or tissue damage.
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 6/5/26
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