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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “112” has been used to designate both a target region of the brain and an aneurysm. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 12-13, 16-17, 29, and 51 are objected to because of the following informalities:
In claim 12, line 2, “approximately 1-4Hz” should read “approximately 1-4 Hz”
In claim 13, line 2, “the Alpha frequency range” should read “an Alpha frequency range”
In claim 13, line 2, “approximately 8-13Hz” should read “approximately 8-13 Hz”
In claim 16, line 2, “approximately 1-4Hz” should read “approximately 1-4 Hz”
In claim 17, line 2, “the Alpha frequency range” should read “an Alpha frequency range”
In claim 17, line 2, “approximately 8-13Hz” should read “approximately 8-13 Hz”
In claim 29, line 1, “Th system of…” should read “The system of…”
In claim 51, line 2, “the Alpha frequency range” should read “an Alpha frequency range”
In claim 51, line 2, “approximately 8-13Hz” should read “approximately 8-13 Hz”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “electronics…configured to” in claims 1, 7, 11, 24, 30, and 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 29 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.
Claim 29 recites the limitation "each ring electrode" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 1, 7-8, 10, 14, 24, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phillips (U.S. PGPub No. 2020/0030617).
Regarding claim 1, Phillips teaches a device (Fig. 1-2, Paragraph 0036, line 2, “device”) for electrical stimulation of a subject's brain (Paragraph 0020, lines 1-2), the device comprising: a case (Fig. 1, Paragraph 0036, lines 2-3, 103) adapted to be implanted against a skull of the subject (Fig. 1-2, Paragraph 0036, lines 12-15); a first electrode (Fig. 1, Paragraph 0036, lines 6-7, 102) disposed on or in the case (Fig. 1); a probe (Fig. 1, Paragraph 0036, line 8, 104) coupled to the case (Fig. 1, Paragraph 0036, lines 7-8) and configured to extend through a burr hole in the skull (Fig. 1, Paragraph 0036, lines 12-13) into the brain of the subject (Fig. 1, Paragraph 0036, lines 9-12); a second electrode (Fig. 1, Paragraph 0036, lines 8-9, 105/106/107/108) disposed on the probe (Fig. 1, Paragraph 0036, lines 8-9) and configured to deliver electrical stimulation (Paragraph 0036, lines 18-21) to a target region of the brain (Paragraph 0037, lines 10-12, 214) and to sense electrical signals of the brain (Paragraph 0036, lines 18-21); and electronics (Paragraph 0036, lines 3-4, “control circuitry” and Paragraph 0036, lines 4-6, “EEG amplifier and an analog to digital converter”) disposed in the case (Paragraph 0036, lines 2-4) and configured to generate electrical pulses (Paragraph 0005, lines 8-10 and Claim 1, lines 21-24), initiate an EEG recording of the subject's brain (Paragraph 0012, lines 6-8), and communicate with (Paragraph 0029, lines 6-10) an external device (Paragraph 0029, lines 1-2, “external programmer”); wherein the device is configured to record EEG signals of the brain (Paragraph 0012, lines 6-8 and Paragraph 0036, lines 4-6) in response to an EEG recording request from the external device (Paragraph 0035, lines 5-14).
Regarding claim 7, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2, “device”) of claim 1, wherein the electronics are configured to generate electric current pulses (Paragraph 0005, lines 8-10 and Claim 1, lines 21-24) between the first electrode and the second electrode (Paragraph 0021, lines 3-5).
Regarding claim 8, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2, “device”) of claim 1, wherein the electric current pulses are configured to follow a path (Paragraph 0021, line 3, “return path”) that proceeds from the second electrode (Paragraph 0021, lines 7-10) through the target region (Paragraph 0021, line 10), through a conductive path at a separate location in the skull from the burr hole (Paragraph 0021, lines 5-6 and 11), and underneath the scalp to the first electrode (Paragraph 0021, lines 11-13).
Regarding claim 10, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2, “device”) of claim 1, further comprising a power source disposed in the case (Fig. 1, Paragraph 0036, lines 2-3, “battery”).
Regarding claim 14, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2, “device”) of claim 1, wherein the device is configured to wirelessly (Paragraph 0032 lines 1-2 and 5-7) transmit the EEG signals to the external device (Paragraph 0035, lines 1-9).
Regarding claim 24, Phillips teaches a system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) for electrical stimulation of a subject's brain (Paragraph 0020, lines 1-2), comprising: a plurality of implantable neurostimulators (Fig. 2, Paragraph 0020, lines 1-4, “one or more modules”) configured to be implanted in a subject (Paragraph 0020, lines 3-4), each of the implantable neurostimulators including: a case (Fig. 2, Paragraph 0037, line 5, 203/208) adapted to be implanted against a skull of the subject (Fig. 2, Paragraph 0037, lines 3-5, 212); a first electrode (Fig. 2, Paragraph 0037, lines 5-6, 204/207) disposed on or in the case (Fig. 2); a probe (Fig. 2, Paragraph 0037, line 8, 202/209) coupled to the case (Fig. 2, Paragraph 0037, lines 8-9) and configured to extend through a burr hole in the skull (Paragraph 0023, lines 1-3) into the brain of the subject(Fig. 2, Paragraph 0037, lines 8-9, 213); a second electrode (Fig. 2, Paragraph 0037, line 10, 201/210) disposed on the probe (Fig. 2, Paragraph 0037, lines 10-11) and configured to deliver electrical stimulation to a target region of the brain (Fig. 2, Paragraph 0037, lines 10-12, 214) and to sense electrical signals of the brain (Paragraph 0036, lines 18-21); and electronics (Paragraph 0036, lines 3-4, “control circuitry” and Paragraph 0036, lines 4-6, “EEG amplifier and an analog to digital converter”) disposed on or in the case (Paragraph 0036, lines 2-4) and configured to generate electrical pulses (Paragraph 0005, lines 8-10 and Claim 1, lines 21-24), initiate an EEG recording of the subject's brain (Paragraph 0012, lines 6-8), and communicate with (Paragraph 0029, lines 6-10) an external device (Paragraph 0029, lines 1-2, “external programmer”); wherein the system is configured to record EEG signals of the brain with the plurality of implantable neurostimulators (Paragraph 0012, lines 6-8 and Paragraph 0036, lines 4-6) in response to an EEG recording request from the external device (Paragraph 0035, lines 5-14).
Regarding claim 30, Phillips teaches the system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) of claim 24, wherein the electronics are configured to generate electric current pulses (Paragraph 0005, lines 8-10 and Claim 1, lines 21-24) between the first electrode and the second electrode (Paragraph 0021, lines 3-5).
Regarding claim 31, Phillips teaches the system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) of claim 24, wherein the electric current pulses of each implanted neurostimulator (Paragraph 0023, line 1, “a first module and a second module”) are configured to follow a path (Paragraph 0023, lines 3-5) that proceeds from the second electrode (Paragraph 0023, lines 5-7) through the target region (Paragraph 0023, lines 7-8), through a conductive path at a separate location in the skull from the burr hole (Paragraph 0023, lines 8-10), and underneath the scalp to the first electrode (Paragraph 0023, lines 10-12).
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 5 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (U.S. PGPub No. 2020/0030617) in view of Lee et al. (U.S. PGPub No. 2011/0137381).
Regarding claim 5, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 1 that comprises the first electrode (Fig. 1, Paragraph 0036, lines 6-7, 102). Phillips does not teach that the first electrode is a ring electrode. Lee, however, discloses devices and methods for preventing and/or treating neurological disorders via electrical stimulation, wherein in one embodiment, an implantable ring electrode is used (Fig. 5B-5C, Paragraph 0171, line 2, 522) for sensing, stimulation, or a combination thereof (Paragraph 0179, lines 1-5).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the subcutaneous electrode of Phillips for the ring electrode of Lee. Employing a ring electrode would provide an improved ability to localize stimulation in the brain (Paragraph 0116, lines 4-7), as recognized by Lee. Thus, the simple substitution of one known element for another producing a predictable result of improving the ability to localize stimulation renders the claim obvious.
Regarding claim 28, Phillips teaches the system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) of claim 24, wherein each implantable neurostimulator includes a first electrode (Fig. 2, Paragraph 0037, lines 5-6, 204/207). Phillips does not teach that the first electrode is a ring electrode. Lee, however, discloses devices and methods for preventing and/or treating neurological disorders via electrical stimulation, wherein in one embodiment, an implantable ring electrode is used (Fig. 5B-5C, Paragraph 0171, line 2, 522) for sensing, stimulation, or a combination thereof (Paragraph 0179, lines 1-5).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the subcutaneous electrode of Phillips for the ring electrode of Lee. Employing a ring electrode would provide an improved ability to localize stimulation in the brain (Paragraph 0116, lines 4-7), as recognized by Lee. Thus, the simple substitution of one known element for another producing a predictable result of improving the ability to localize stimulation renders the claim obvious.
Regarding claim 29, Phillips teaches the system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) of claim 24, wherein each implantable neurostimulator includes a first electrode (Fig. 2, Paragraph 0037, lines 5-6, 204/207) and a case (Fig. 2, Paragraph 0037, line 5, 203/208).
Phillips does not teach that the first electrode is a ring electrode. Lee, however, discloses devices and methods for preventing and/or treating neurological disorders via electrical stimulation, wherein in one embodiment, an implantable ring electrode is used (Fig. 5B-5C, Paragraph 0171, line 2, 522) for sensing, stimulation, or a combination thereof (Paragraph 0179, lines 1-5).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the subcutaneous electrode of Phillips for the ring electrode of Lee. Employing a ring electrode would provide an improved ability to localize stimulation in the brain (Paragraph 0116, lines 4-7), as recognized by Lee. Thus, the simple substitution of one known element for another producing a predictable result of improving the ability to localize stimulation renders the claim obvious.
Phillips also does not teach that the electrode is integrated into the case. However, it would have been prima facie obvious to one of ordinary skill in the art to make the electrode integrated into the case, since it has been held that forming in one piece an article that has formerly been formed in more than one piece and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) MPEP 2144.04-V-B.
Claims 11, 15, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (U.S. PGPub No. 2020/0030617) in view of Causevic (U.S. PGPub No. 2011/0112426).
Regarding claim 11, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 1, wherein the electronics are further configured to analyze the EEG signals (Paragraph 0012, lines 3-4). Phillips does not teach that the EEG signals are analyzed to identify an intracerebral hemorrhage in the target region.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic further teaches that the extracted features can be used to provide a prognostic indicator of a disease state (Paragraph 0026, lines 7-9), such as an intracerebral hemorrhage (Paragraph 0030, lines 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic to include using signal feature extraction techniques to analyze the EEG signals to identify an intracerebral hemorrhage in the target region. Doing so would allow intracerebral hemorrhage in the target region to be rapidly and accurately identified (Paragraph 0025, lines 3-6), as recognized by Causevic.
Regarding claim 15, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 14, wherein the external device is further configured to analyze the
EEG signals (Paragraph 0012, lines 5-6). Phillips does not teach that the EEG signals are analyzed to identify an intracerebral hemorrhage in the target region.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic further teaches that the extracted features can be used to provide a prognostic indicator of a disease state (Paragraph 0026, lines 7-9), such as an intracerebral hemorrhage (Paragraph 0030, lines 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic to include using signal feature extraction techniques to analyze the EEG signals to identify an intracerebral hemorrhage in the target region. Doing so would allow intracerebral hemorrhage in the target region to be rapidly and accurately identified (Paragraph 0025, lines 3-6), as recognized by Causevic.
Regarding claim 32, Phillips teaches the system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) of claim 24, wherein the electronics of each implanted neurostimulator are further configured to analyze the EEG signals (Paragraph 0012, lines 3-4). Phillips does not teach that the EEG signals are analyzed to identify an intracerebral hemorrhage in the target region.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic further
teaches that the extracted features can be used to provide a prognostic indicator of a disease state (Paragraph 0026, lines 7-9), such as an intracerebral hemorrhage (Paragraph 0030, lines 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic to include using signal feature extraction techniques to analyze the EEG signals to identify an intracerebral hemorrhage in the target region. Doing so would allow intracerebral hemorrhage in the target region to be rapidly and accurately identified (Paragraph 0025, lines 3-6), as recognized by Causevic.
Claims 12-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (U.S. PGPub No. 2020/0030617) in view of Causevic (U.S. PGPub No. 2011/0112426) as applied to claims 11 and 15 above, and further in view of Transcranial Doppler Combined with Quantitative EEG Brain Function Monitoring and Outcome Prediction in Patients with Severe Acute Hemorrhage, 2018 (herein referred to as Chen).
Regarding claim 12, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 11. Phillips does not teach that the analyzing the EEG signals further
comprises identifying increased slow wave activity in a Delta frequency range of approximately 1-4Hz.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic also teaches that a linear algorithm can be used to extract frequency features by dividing the signal into Delta, Theta, Alpha, Beta, or Gamma bands (Paragraph 0068, lines 1-5). Causevic teaches that the Delta frequency ranges up to about 3 Hz (Paragraph 0044, lines 1-2).
Chen, however, discloses a study that used both transcranial doppler and quantitative EEG to monitor the brain function and predict prognosis outcomes for patients with severe acute intracerebral hemorrhage (Abstract). Chen’s findings determined that slower frequency band delta power increased with the aggravation of brain injury (Page 7, Left Column, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic and Chen to include that analyzing the EEG signals further comprises identifying increased slow wave activity in a Delta frequency range of approximately 1-4 Hz. Doing so would ensure that the frequency bands of each EEG signal can be extracted in order to identify the Delta frequency band (Paragraph 0068, lines 1-5), as recognized by Causevic. Doing so would also ensure that increases of the Delta frequency band would be used as an indicator for intracerebral hemorrhage (Page 7, Left Column, lines 3-6), as recognized by Chen.
Furthermore, it would have been obvious to one of ordinary skill in the art to specify that the Delta frequency ranges from approximately 1-4Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 13, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 11. Phillips does not teach that the analyzing the EEG signals further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13Hz.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic also teaches that a linear algorithm can be used to extract frequency features by dividing the signal into Delta, Theta, Alpha, Beta, or Gamma bands (Paragraph 0068, lines 1-5). Causevic teaches that the Alpha frequency ranges from about 8 Hz to about 12 Hz (Paragraph 0046, lines 1-2).
Chen, however, discloses a study that used both transcranial doppler and quantitative EEG to monitor the brain function and predict prognosis outcomes for patients with severe acute intracerebral hemorrhage (Abstract). Chen’s findings determined that faster frequency band alpha power decreased with the aggravation of brain injury (Page 7, Left Column, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic and Chen to include that analyzing the EEG signals further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13 Hz. Doing so would ensure that the frequency bands of each EEG signal can be extracted in order to identify the Alpha frequency band (Paragraph 0068, lines 1-5), as recognized by Causevic. Doing so would also ensure that decreases of the Alpha frequency band would be used as an indicator for intracerebral hemorrhage (Page 7, Left Column, lines 3-6), as recognized by Chen.
Furthermore, it would have been obvious to one of ordinary skill in the art to specify that the Alpha frequency ranges from approximately 8-13Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 16, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 15. Phillips does not teach that the analyzing the EEG signals further
comprises identifying increased slow wave activity in a Delta frequency range of approximately 1-4Hz.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic also teaches
that a linear algorithm can be used to extract frequency features by dividing the signal into Delta, Theta, Alpha, Beta, or Gamma bands (Paragraph 0068, lines 1-5). Causevic teaches that the Delta frequency ranges up to about 3 Hz (Paragraph 0044, lines 1-2).
Chen, however, discloses a study that used both transcranial doppler and quantitative EEG to monitor the brain function and predict prognosis outcomes for patients with severe acute intracerebral hemorrhage (Abstract). Chen’s findings determined that slower frequency band delta power increased with the aggravation of brain injury (Page 7, Left Column, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic and Chen to include that analyzing the EEG signals further comprises identifying increased slow wave activity in a Delta frequency range of approximately 1-4 Hz. Doing so would ensure that the frequency bands of each EEG signal can be extracted in order to identify the Delta frequency band (Paragraph 0068, lines 1-5), as recognized by Causevic. Doing so would also ensure that increases of the Delta frequency band would be used as an indicator for intracerebral hemorrhage (Page 7, Left Column, lines 3-6), as recognized by Chen.
Furthermore, it would have been obvious to one of ordinary skill in the art to specify that the Delta frequency ranges from approximately 1-4Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 17, Phillips teaches the device (Fig. 1-2, Paragraph 0036, line 2,
“device”) of claim 15. Phillips does not teach that the analyzing the EEG signals further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13Hz.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic also teaches that a linear algorithm can be used to extract frequency features by dividing the signal into Delta, Theta, Alpha, Beta, or Gamma bands (Paragraph 0068, lines 1-5). Causevic teaches that the Alpha frequency ranges from about 8 Hz to about 12 Hz (Paragraph 0046, lines 1-2).
Chen, however, discloses a study that used both transcranial doppler and quantitative EEG to monitor the brain function and predict prognosis outcomes for patients with severe acute intracerebral hemorrhage (Abstract). Chen’s findings determined that faster frequency band alpha power decreased with the aggravation of brain injury (Page 7, Left Column, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Phillips to incorporate the teachings of Causevic and Chen to include that analyzing the EEG signals further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13 Hz. Doing so would ensure that the frequency bands of each EEG signal can be extracted in order to identify the Alpha frequency band (Paragraph 0068, lines 1-5), as recognized by Causevic. Doing so would also ensure that decreases of the Alpha frequency band would be used as an indicator for intracerebral hemorrhage (Page 7, Left Column, lines 3-6), as recognized by Chen.
Furthermore, it would have been obvious to one of ordinary skill in the art to specify that the Alpha frequency ranges from approximately 8-13Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Claims 43 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (U.S. PGPub No. 2011/0137381) in view of Phillips (U.S. PGPub No. 2020/0030617) and Causevic (U.S. PGPub No. 2011/0112426).
Regarding claim 43, Lee teaches a method of monitoring (Paragraph 0013, lines
1-3) an aneurysm in a brain (Paragraph 0048, line 29) of a subject (Paragraph 0013, line 5, “patient”) that involves detecting electrical activity within the brain (Paragraph 0013, lines 5-6 and Paragraph 0139, lines 1-3), and analyzing the electrical activity within the brain to determine whether an abnormal neurological event has occurred (Paragraph 0013, lines 6-8).
Lee does not teach that the method includes initiating an EEG recording in one or more implanted neurostimulator devices with an external device; analyzing the EEG recording to identify an intracerebral hemorrhage in the brain; and indicating to the subject or to a medical provider that the intracerebral hemorrhage has been identified.
Phillips teaches a system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) for electrical stimulation of a subject's brain (Paragraph 0020, lines 1-2), comprising: a plurality of implantable neurostimulators (Fig. 2, Paragraph 0020, lines 1-4, “one or more modules”) configured to be implanted in a subject (Paragraph 0020, lines 3-4). Phillips teaches that each of the neurostimulators can sense electrical signals of the brain (Paragraph 0036, lines 18-21). Phillips also teaches that the system is configured to record EEG signals of the brain with the plurality of implantable neurostimulators (Paragraph 0012, lines 6-8 and Paragraph 0036, lines 4-6) in response to an EEG recording initiation from (Paragraph 0035, lines 5-14) an external device (Paragraph 0029, lines 1-2, “external programmer”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Lee to incorporate using the system disclosed in Phillips to include using one or more implanted neurostimulator devices and an external device to initiate EEG recordings in the one or more implanted devices. Doing so would ensure that the EEG recording could begin as a result of a command from the external device (Paragraph 0035, lines 5-14), as recognized by Phillips.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic teaches that the extracted features can be used to provide a prognostic indicator of a disease state (Paragraph 0026, lines 7-9), such as an intracerebral hemorrhage (Paragraph 0030, lines 6-7). Causevic also teaches that the neuromarker could be displayed to the subject or to a medical provider to provide prognosis information (Paragraph 0099, lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee to incorporate the teachings of Causevic to include using signal feature extraction techniques to analyze the EEG signals to identify an intracerebral hemorrhage in the target region, and displaying prognosis information to the subject or to a medical provider. Doing so would allow intracerebral hemorrhage in the target region to be rapidly and accurately identified (Paragraph 0025, lines 3-6), and subsequently displayed to the subject or a medical provider (Paragraph 0099, lines 1-7), as recognized by Causevic.
Regarding claim 52, Lee teaches the method (Paragraph 0013, lines 1-3) of claim
43. Lee does not teach that the method further comprises providing electrical stimulation to the brain with the one or more implanted neurostimulator devices.
Phillips teaches a system (Fig. 1-2, Paragraph 0020, lines 1-4, system of multiple modules and Claim 18) for electrical stimulation of a subject's brain (Paragraph 0020, lines 1-2), comprising: a plurality of implantable neurostimulators (Fig. 2, Paragraph 0020, lines 1-4, “one or more modules”). Phillips also teaches that the neurostimulators are configured to deliver electrical stimulation to a target region of the brain (Fig. 2, Paragraph 0037, lines 10-12, 214).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Lee to incorporate using the system disclosed in Phillips to include that the one or more implanted neurostimulator devices are configured to provide electrical stimulation to the brain. Doing so would ensure that effective electrical stimulation reaches the region of the brain responsible for the disorder being treated (Paragraph 0009, lines 2-4), as recognized by Phillips.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (U.S. PGPub No. 2011/0137381) in view of Phillips (U.S. PGPub No. 2020/0030617) and Causevic (U.S. PGPub No. 2011/0112426) as applied to claim 43 above, and further in view of Transcranial Doppler Combined with Quantitative EEG Brain Function Monitoring and Outcome Prediction in Patients with Severe Acute Hemorrhage, 2018 (herein referred to as Chen).
Regarding claim 51, Lee teaches the method (Paragraph 0013, lines 1-3) of claim
43. Lee does not teach that analyzing the EEG recording further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13Hz.
Causevic, however, teaches systems and methods for monitoring brain activity that
involve recording EEG signals (Paragraph 0037, lines 7-9) and then extracting various
signal features from the EEG signals (Paragraph 0063, lines 1-5). Causevic also teaches that a linear algorithm can be used to extract frequency features by dividing the signal into Delta, Theta, Alpha, Beta, or Gamma bands (Paragraph 0068, lines 1-5). Causevic teaches that the Alpha frequency ranges from about 8 Hz to about 12 Hz (Paragraph 0046, lines 1-2).
Chen, however, discloses a study that used both transcranial doppler and quantitative EEG to monitor the brain function and predict prognosis outcomes for patients with severe acute intracerebral hemorrhage (Abstract). Chen’s findings determined that faster frequency band alpha power decreased with the aggravation of brain injury (Page 7, Left Column, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee to incorporate the teachings of Causevic and Chen to include that analyzing the EEG signals further comprises identifying reduced Alpha activity in the Alpha frequency range of approximately 8-13 Hz. Doing so would ensure that the frequency bands of each EEG signal can be extracted in order to identify the Alpha frequency band (Paragraph 0068, lines 1-5), as recognized by Causevic. Doing so would also ensure that decreases of the Alpha frequency band would be used as an indicator for intracerebral hemorrhage (Page 7, Left Column, lines 3-6), as recognized by Chen.
Furthermore, it would have been obvious to one of ordinary skill in the art to specify that the Alpha frequency ranges from approximately 8-13Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Young (KR-20220097143) teaches a wireless transmission module for internal EEG electrodes for brain disease analysis, wherein the electrodes measure EEG signals, discriminate frequency bands in each EEG signal, and discriminate brain waves into normal/abnormal brain waves (Abstract).
Bardakjian et al. (WIPO Pub. No. 2015/0066791) teaches a method of processing EEG signals obtained from a subject by determining what EEG signals are in a low frequency range, and using data to identify possible seizure zones of the subject’s brain (Abstract).
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/H.A.H./Patent Examiner , Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
