Non-Final Office Action
Introduction
1. For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
2. This Office Action addresses U.S. Application No. 18/225,755 (hereinafter also referred to as ‘755 or the instant application) which is a reissue application of U.S. Patent Application Ser. No. 16/152,778, filed October 5, 2018 (hereinafter also referred to as ‘778 or the parent application), entitled Multicomponent Brain-based Electromagnetic Biosignal Detection System, and issued July 27, 20211 as U.S. Patent No. 11,071,493 (hereinafter also referred to as the original patent), which is a continuation of U.S. Patent Application Ser. No. 15/165,309 filed May 26, 2016, now abandoned, which is a continuation of U.S. Patent Application Ser. No. 14/062,573, filed Oct. 24, 2013, now abandoned, which claims the benefit of priority of U.S. Provisional Application No. 61/717,997, filed Oct. 24, 2012, and of U.S. Provisional Application No. 61/790,007, filed Mar. 15, 2013.
3. Based upon Applicant’s statements as set forth in the instant application and after the
Examiner’s independent review of ‘493 itself and its prosecution history, the Examiner finds no current ongoing litigation involving ‘493. See Litigation Search Report of record. Also based upon the Examiner’s independent review of ‘493 itself and the prosecution history, the Examiner cannot locate any other previous reexaminations, supplemental examinations, or certificates of correction.
4. The ‘493 patent issued with claims 1-20 (hereinafter also referred to as the patent claims). Claim 1 is an independent claim. A preliminary amendment filed concurrently with the application on July 25, 2023 was entered. The preliminary amendment added claims 21-47 of which claims 21 and 30-32 are independent claims.
5. As of the date of this Office Action, the status of the claims is:
Claims 1-47 are pending.
Claims 1-47 are examined.
Claims 1-47 are objected to and/or rejected as set forth infra.
Priority
6. Based upon a review of the instant application, the Examiner finds that Patent Owner is claiming benefit to U.S. Provisional Application No. 61/717,997 filed Oct. 24, 2012, and of U.S. Provisional Application No. 61/790,007 filed Mar. 15, 2013.
Notice of Pre-AIA or AIA Status
7. Because the effective filing date of claims of the instant application after September 16, 2012, the AIA (“AIA ”) provisions apply thereto. See also paragraph 1, supra.
Reissue
ADS
8. The Application Data Sheet (ADS) is objected to because: on page 3, “Domestic
Benefit/National Stage Information”, “reissued” should be --reissue--.
Note any corrected ADS must identify the information being changed with underlining
for insertions and strike-though or brackets for text removed as required by 37 CFR 1.76(c)(2).
See MPEP 2920.02 and Quick Start Guide for Corrected Web-based ADS at:
https://www.uspto.gov/sites/default/files/documents/Corrected-WebADS-QSG.pdf.
Additionally, the corrected ADS should be filed with a request for a corrected filing
receipt. See MPEP 601.05(a) (II).
Preliminary Amendment
9. The amendment filed July 25, 2023 does not comply with 37 CFR 1.173 (b)(2), i.e. Claims, (d), i.e. Changes shown by markings, and (c), i.e. Status of claims and support for claim changes. Appropriate correction is required. See also MPEP § 1453(II).
Specifically, the parentheticals of the patent claims should be --(Original)-- rather than “(Previously Presented)”.
Furthermore, whenever there is an amendment to the claims pursuant to paragraph (b) of section 37 CFR 1.173, there must also be supplied, on pages separate from the pages containing the changes, the status, as of the date of the amendment, of all patent claims and of all added
claims and an explanation of the support in the disclosure of the patent for the changes made to the patent claims as well as for any newly added claims. See pages 16-20 of the 7/25/2023 Remarks. Specifically, the claim language of claim 32 discussed is not the same as that of claim 32 as presented.
Any further response failing to provide an explanation of support in the disclosure of the patent for the claims will be held non-compliant and a Notice of Non-Compliance requiring a supplemental paper correctly amending the reissue application in compliance with 37 CFR 1.1739 (c) will be issued.
Recapture
10. Claims 21-47 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
Below are the pertinent Examiner’s findings of fact relevant to this rejection:
The parent application ‘057 was filed with claims 1-20 on October 5, 2018. On September 14, 2020, claims 1-3, 6-10, 13-15 and 18-20 were rejected on art and dependent claims 4-5, 11-12 and 16-17 were objected to and indicated as containing allowable subject matter.
A response was filed on March 15, 2021, claim 1 (the only independent claim) was amended as follows:
(Currently Amended) A system for detecting a multicomponent brain-based electromagnetic bio-signal comprising:
at least two bio-signal sensors embedded within walls of an oral attachment device configured to be positioned in an oral cavity to bring into contact the at least two bio-signal sensors with an oral tissue, wherein the at least two bio-signal sensors include at least two concave bio-signal electrodes configured to contact gums or at least two convex bio-signal electrodes configured to contact hard palate tissue;
a computer processing unit communicatively coupled to the at least two bio-signal sensors, wherein the at least two bio-signal sensors are configured to detect a raw oral multicomponent electromagnetic bio-signal at the oral tissue and send the raw oral multicomponent electromagnetic bio-signal to
(Bold emphasis indicates the subject matter of originally filed claims 4 and 5 added.)
Claims 4-5 were correspondingly amended. Concurrent remarks by Applicant set forth:
In response to the Office Action, Applicant respectfully submits an amendment to … include all of the limitations of claims 4 and 5 in independent claim 1, as suggested as allowable by the Examiner at page 5 of the Office Action….
Applicant has included all of the limitations of original claims 4 and 5 in independent claim 1 as suggested as allowable over all of the cited references under 35 U.S.C. § 102 and 103. Applicant respectfully requests that these rejections be withdrawn and all of the presented amended claims be allowed.
The patent issued on July 27, 2021 with claims 1-20. The reasons for allowance set forth:
In regards to claim 1, the prior art of record does not teach or suggest a system as claimed by Applicant, the at least two bio-signal sensors include at least two concave bio-signal electrodes configured to contact gums or at least two convex bio-signal electrodes configured to contact hard palate tissue.
A reissue will not be granted to “recapture” claimed subject matter which was surrendered in an application to obtain the original patent. See MPEP § 1412.20. A three step process is used to apply the recapture rule:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.” See MPEP §1412.020).
Regarding step 1, upon review of claims 21-47 of the present reissue application in comparison to claims 1-20 of the ‘493 patent, it is found that the July 25, 2023 amendment has broadened the claims by the omission of limitations, e.g. the at least two bio-signal sensors include at least two concave bio-signal electrodes configured to contact gums or at least two convex bio-signal electrodes configured to contact hard palate tissue. Thus, claims 21-47 herein are broader in at least these respects than the claims in the ‘493 patent.
Regarding step 2, it is found that such broadening aspects relate to subject matter surrendered during prosecution of the ‘778 application leading to the ‘493 patent. As noted above in the findings of fact, the ‘778 application was allowed after the features of “the at least two bio-signal sensors include at least two concave bio-signal electrodes configured to contact gums or at least two convex bio-signal electrodes configured to contact hard palate tissue” were specifically added and/or argued as making the claims allowable over prior art rejections made in the application. Thus, those features consistent with the arguments/amendments are found to be a surrender-generating limitation. See also MPEP 1412.02,II, B (i.e. “Where a claim in a reissue application is broadened in some respect as compared to the patent claims, the examiner must next determine whether the broadening aspect(s) of that reissue claim relate(s) to subject matter that applicant previously surrendered during the prosecution of the original application (which became the patent to be reissued). The ‘original application’ includes the patent family’s entire prosecution history. MBO Laboratories, Inc. v. Becton, Dickinson & Co., 602 F.3d 1306, 94 USPQ2d 1598 (Fed. Cir. 2010).”)
Regarding step 3, there is no addition of a new limitation that is related to the surrendered subject matter, i.e. “the at least two bio-signal sensors include at least two concave bio-signal electrodes configured to contact gums or at least two convex bio-signal electrodes configured to contact hard palate tissue”, and thereby, the Examiner does not find any materially narrowing aspects of the claims, i.e. only narrower regarding unrelated aspects.
Claims 21-47 and those depending therefrom do not include/have eliminated the surrendered subject matter discussed in the previous two paragraphs. If reissue claims are broader by entirely eliminating surrender-generating limitations” and are narrower in unrelated aspect(s) (e.g. an external device communicatively coupled to the at least one computer processor and configured to display information for diagnosing of one or more of a disease, disorder, and condition of a user based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal), then a recapture rejection under 35 U.S.C. 251 is proper and must be made for that claim. See MPEP 1412.02, II, C and III, B, 1.
In view of the forgoing, it is concluded herein that the claims improperly recapture subject matter explicitly surrendered during prosecution of the “original application”.
Reissue Declaration
11. The reissue oath/declaration filed July 10, 2023 is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The oath or declaration must properly identify at least one error under 35 U.S.C. 251 being relied upon as a basis for the reissue (37 CFR 1.175(a)). Specific changes or amendments to the claims must be identified. Any error in the claims must be identified by reference to the specific claim(s) and the specific claim language wherein lies the error. If new claims are presented, their difference from the original claims must be pointed out. See MPEP §1414. If the reissue is a broadening reissue, a claim that the application seeks to broaden must be identified. (Note: A statement that “the patent is wholly or partly inoperative by reason of claiming more or less than applicant had a right to claim” is NOT an unequivocal statement of an intent to broaden.) Furthermore the error that supports the reissue is not limited to an error in the claims but may exist elsewhere in the patent (e.g., in the specification, drawings, etc.) as long as the error is an error that causes the patent to be wholly or partly inoperative or invalid.
The July 25, 2023 declaration states “the original patent to be wholly or partly inoperative or invalid” “by reason of the patentee claiming more or less than he had the right to claim in the patent”. The declaration continues:
New claims 21-47 are broadening reissue claims with respect to original claim 1 that are
directed to overlooked aspects of the original disclosure as set forth in the accompanying
preliminary amendment.
However, the aspects of claims 21-47 considered “overlooked’ as compared to original claim 1 have not been specified. Furthermore, any aspects of claims 21-47 considered “overlooked” as to the remainder of the original claims 2-20 and the claims of the patent family’s entire prosecution history have not been specified, i.e. see paragraph 2 above.2
12. Claims 1-47 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
13. The disclosure is objected to because of the following informalities: In the abstract, “brave” should be --brain--. Col. 3, lines 26-32 appears to be missing a word or word(s). Col. 7, lines 30-35 and 58-65 appear to be missing a word or words. Col. 8, lines 3-8 appears to be missing a word or words. In col. 9, line 23, after “unit”, --650-- should be inserted.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). At the very least (see also paragraphs 18 and/or 19 below), clear antecedent basis for “generat[ing] a diagnosis of a condition following comparing data…of the condition” as claimed in claims 8, 11, and 16 should be set forth. Clear antecedent basis for ““generat[ing] a command based on data from data…signal” as claimed in claims 7 and 10 should be set forth.
Also, the preamble of claim 32 recites an “apparatus for detecting brain waves and subcomponents of internal body multicomponent brain based electromagnetic bio-signals”. However, in light of the definition of the terminology “multicomponent brain based signal”3, the description of internal body subcomponents, e.g. raw oral brain-based electromagnetic bio signal subcomponent4, the description of raw oral brain-based electromagnetic bio signal subcomponents representing brain waves5 as well as the description of raw scalp EEG brain waves6, the terminology “brain waves and subcomponents of internal body multicomponent brain based electromagnetic bio-signals” is unclear7. For example, is it the same as “multicomponent brain-based signal” or not? Does “brain waves” encompass both that of raw oral brain-based electromagnetic bio signal subcomponent as well as those of the raw scalp EEG brain waves? Does “subcomponents” include an raw oral brain-based electromagnetic bio signal subcomponent or not?
Appropriate correction is required.
Drawings
14. The drawings filed July 10, 2023 are objected to because:
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description, i.e. the reference numerals set forth in col. 5, line 37-col. 8, line 47, and because they include the following reference character(s) not mentioned in the description, i.e. numeral 105 in Figure 7. Continuing, in Figure 6, arrows from the numerals to the respective signals should be provided. In Figure 10, “EXTENAL” should be --EXTERNAL--.
The drawings are also objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, an external device configured to display information for diagnosing as claimed in claims 21-29 and 32-47, a tissue stimulation device as claimed in claims 30 and 46, a controllable device that performs a task as claimed in claims 31 and 47, a field programmable gate array as claimed in claim 33, an oral airway as claimed in claim 37, a nasal clip as claimed in claim 38, an implantable device as claimed in claim 39 and an external device configured to interpret and display information as claimed in claim 44 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.173 and 1.84 are required in reply to the Office action to avoid abandonment of the application. 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
15. Claims 7-47 are objected to because of the following informalities: Claim 7, lines 1-3, i.e. “wherein…unit and”, are redundant, see, e.g., lines 9-11 of claim 1, i.e. wherein the at least…unit. This also applies to claims 8, 10, 11 and 16. In claims 21 and 30-31, line 2, “retained” should be --retainable--. In claim 32, lines 10-12 are unclear, i.e. too many words. On line 15 “and or” should be --and/or--. In claim 39, “implanted” should be --implantable--. 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. See MPEP 2111. It is further noted it is improper to import claim limitations from the specification, i.e., a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. See MPEP §2111.01(11). Therefore, unless Applicant for patent has provided a lexicographic definition for the term, see MPEP §211l.0l(IV), or 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked, Examiners will interpret the limitations of the pending and examined claims using the broadest reasonable interpretation.
A. Lexicographic Definitions
A first exception to the prohibition of reading limitations from the specification into the claims is when the Applicant for patent has provided a lexicographic definition for the term. See MPEP §2111.01(IV). Following an independent review of the claims in view of the specification herein, it was found that Patent Owner did provide definitions related to claim terms with reasonable clarity, deliberateness and precision.
“For the purposes of this invention, ‘multicomponent brain-based signal’ is used to describe this collection of sub-component bio-signals8, as the primary component bio-signals of interest emanates [sic] from the brain. The multicomponent brain-based signal can include bio-electromagnetic signals, cardiac bio-electromagnetic bio-signals, local tissue bio-electromagnetic signals; eye dipole bioelectric bio-signals; muscle bio-electromagnetic bio-signals; tongue bio-electromagnetic bio-signals; cardiac related pulsatile bio-signals; respiration related pulsatile bio-signals; movement related bio-signals; biomechanical bio-signals; bio-acoustic bio-signals.” (Emphasis added.)
Col. 2, lines 17-28.
B. Claim Interpretation Under 35 U.S.C. § 112 (6th ¶)
A second exception to the prohibition of reading limitations from the specification into the claims is when the claimed feature is written as a means-plus-function or a step-plus-function. See 35 U.S.C. §112(6th ¶) and MPEP §2181-2183. As noted in MPEP §2181, a three prong test is used to determine the scope of a means-plus-function or step-plus-function limitation in a claim:
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.
16. 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 limitation(s) is/are:
1. in claim 1, “a computer processing unit” “….includes an [independent component analysis] processor that isolates at least one primary raw brain-based multicomponent electromagnetic bio-signal from a plurality of other subcomponents within the raw oral multicomponent electromagnetic bio-signal”,
2. in claim 7, “the computer processing unit is configured to generate a command based on data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio-signal”,
3. in claim 8, “the computer processing unit is configured to generate a diagnosis of a condition following comparing data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio signal to predetermined baseline data for diagnosis of the condition”,
4. in claim 10, “the computer processing unit is configured to generate a command based on data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio-signal”,
5. in claim 11, “the computer processing unit is configured to generate a diagnosis of a condition following comparing data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio signal to predetermined baseline data for diagnosis of the condition”,
6. in claim 16, “the computer processing unit is configured to generate a diagnosis of a condition following comparing data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio signal to predetermined baseline data for diagnosis of the condition”,
7. in claims 21, and 30-31, [the plurality of electrodes and]9 the at least one computer processor are configured to automatically determine a primary subcomponent brain-based bio-signal from a multi-component brain-based bio-signal”,
8. in claim 21, “an external10 device [communicatively coupled to the at least one computer processor and] configured to display information for diagnosing of one or more of a disease, disorder, and condition of a user based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal”,
9. in claims 24, 26 and 28, “wherein the external device and the at least one computer processor are configured to display information for diagnosing” “sleep apnea”, “a concussion”, and “a seizure”, respectively,
10. in claim 30, “a tissue stimulation device [coupled to the at least one computer processor] that stimulates based on detection of a condition of the user from the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal”,
11. in claim 31, “a controllable device [coupled to the at least one computer processor] that performs a task for the user based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal”,
12. in claim 32, “a computer processing unit [communicatively coupled to the bio-signal sensors, wherein the bio-signal sensors are configured to detect a raw multicomponent electromagnetic bio-signal and send the raw multicomponent electromagnetic bio-signals to the computer processing unit, said computer processing unit] programmed to isolate at least one primary raw brain wave bio-signal within the brain-based multicomponent electromagnetic bio-signal from a plurality of other subcomponents within the raw multicomponent electromagnetic bio-signal including and isolate [sic] one or more of eye waves, cardiac waves, respiratory waves derived from cardiac waves, muscle waves, local tissue waves, nervous system tissue waves, and non-physiological waves”,
13. in claim 32, “said computer processing unit is configured to further separate the raw brain waves of the brain-based multicomponent signal into a plurality of brain wave bands and or brain wave patterns”,
14. in claim 32, “an external device [communicatively coupled to the at least one computer processor and] configured to display information for diagnosing of one or more of a disease, disorder, condition of a human or an animal, wherein the diagnosing is based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal’,
15. in claim 44, “the external device and the at least one computer processing unit are configured to interpret and display information for one or more of sleep apnea, sleep stages, concussion, brain injury, seizure, and brain function”,
16. in claim 46, “a tissue stimulation device [coupled to the at one computer processing unit]”,
17. in claim 47, “a controllable device [coupled to the at least one computer processing unit] performs a task for the user determined from the multicomponent brain-based bio-signal”,
When a claim term lacks the word “means,” the presumption can be overcome and §112, para. 6 will apply if the challenger demonstrates that the claim term [1] fails to “recite sufficiently definite structure” or else [2] recites “function without reciting sufficient structure for performing that function.” Watts [v. XL Sys., Inc.], 232 F.3d [877] at 880.
Williamson, 792 F.3d at 1349 (en banc) (emphasis added; bracketed numbering added). See also Personalized Media Communications, LLC v. International Trade Commission, 161 F. 3d 696, 704 (Fed. Cir. 1998)).
As to elements 8-9 and 14-15, the Examiner notes as to the function(s) claimed (i.e. “to display information for diagnosing of one or more of a disease, disorder, and condition of a user based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal” (claim 21), “to display information for diagnosing” “sleep apnea” (claim 24), “a concussion” (claim 26), and “a seizure” (claim 28), respectively, “to display information for diagnosing of one or more of a disease, disorder, condition of a human or an animal, wherein the diagnosing is based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal” (claim 32), and “to interpret and display information for one or more of sleep apnea, sleep stages, concussion, brain injury, seizure, and brain function” (claim 44) are performed by an “external device”, that while the term “external device” implies structure, as to elements above, it does not do so in such a manner that one of ordinary skill in the art would understand it to be sufficient structure for performing the claimed function(s). Williamson, 792 F.3d at 1349. Thus, in light of Williamson above, the limitations 8-9 and 14-15 with regard to the “external device” above overcome the presumption that § 112(f) is not invoked when a phrase does not use the term “means”.
As to elements 10 and 16 and elements 11 and 17, the Examiner notes as to the function(s) claimed (i.e. “stimulates based on detection of a condition of the user from the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal” (claim 30) and “tissue stimulation” (claim 46) and “performs a task for the user based on the primary subcomponent brain-based bio-signal determined from the multi-component brain-based bio-signal”(claim 31) and “performs a task for the user determined from the multicomponent brain-based bio-signal” (claim 47) are performed by a “device” and “a controllable device”, respectively, that while the terms “tissue stimulation device” and “controllable device” implies structure, as to the elements above, it does not do so in such a manner that one of ordinary skill in the art would understand it to be sufficient structure for performing the claimed function(s). Williamson, 792 F.3d at 1349. Thus, in light of Williamson the limitations of 10-11 and 16-17 with regard to “tissue stimulation device” and “controllable device” above overcome the presumption that § 112(f) is not invoked when a phrase does not use the term “means”.
The Examiner further notes that the function(s) claimed in elements 1-7, 9, 12-13 and 15 are performed by a processor. While the term “processor”11 or “computer processing unit” implies structure, it does not do so in such a manner that one of ordinary skill in the art would understand it to be sufficient structure for performing the claimed function(s). Williamson, 792 F.3d at 1349. Thus, in light of Williamson above, the limitations above overcome the presumption that § 112(f) is not invoked when a phrase does not use the term “means”.
Specifically, for a computer-implemented § 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite. See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) ("[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat Techs. Australia PTY Ltd. v. Int’1 Game Tech., 521 F.3d 1328, 1336-37, 86 USPQ2d 1235, 1242 (Fed. Cir. 2008). In this instance, the structure corresponding to a § 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999). The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy [§ 112(f)]. It was required, however, to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.)) An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or "In any other manner that provides sufficient structure." Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
Thus, 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. Thus, the Examiner looks to the disclosure to construe the claim limitations to cover the corresponding structure described therein under the above guidance.
As to elements 1 and 7 above, “a computer processing unit”12 as claimed (“communicatively coupled to the at least two bio-signal sensors, …. send the raw oral multicomponent electromagnetic bio-signal to the computer processing unit, said computer processing unit includes an independent component analysis processor….a plurality of brain wave band pass filters that are configured to further separate the raw brain-based multicomponent signal into a plurality of frequency brain wave bands” (claim 1) and “are configured to automatically determine a primary subcomponent brain-based bio-signal from a multi-component brain-based bio-signal”(claim 7)) is described in Fig. 10, EXTENAL [sic] UNIT: PROGRAMMED, col. 6, lines 42-50 (The external unit 650 includes a receiver unit 651, … an Independent Component Analysis (“ICA”) processor 700, a raw brain-based multicomponent bio-signal component analyzer 750,…, brain wave filters 1-N 751, 752 and 753”), col. 7, lines 34-35 (“the ICA processor 700 of a computer or Field Programmable Gate Array (FPGA).”), col. 8, lines 34-40 (“Following separation into individual subcomponent signals the raw brain-signal can be further analyzed or separated into various frequency bands using band-pass filters 750”), Fig. 15, element 650, col. 9, lines 18-24 (“FIG. 15 shows … an example of an oral attachment mouthguard 800 with electrodes … and transmission system, and an exemplary embodiment of the external unit 650. External unit can be a smartphone, computer or other computing device.”), col. 3, lines 28-36 (“a sensor in the oral cavity may be coupled to one or more electronic processors capable of electronically digitizing, amplifying, attenuating, filtering and normalizing the multi-component brain-based bio-signals as needed. The computer processor may also be capable of extracting, isolating or otherwise dividing sub-component signals from the multi-component brain-based bio-signals, and optionally classifying and analyzing the sub-component signals.”), Fig. 12, sentence bridging cols. 8-9 (“In some embodiments the internal oral unit 800 electronic circuits 601 that perform some or all of the functions described above.”) and col. 9, line 62-col. 10, line 10 (“In some embodiments, signal processing (including filtering, amplification, digitizing, storage etc.) and recording of some or all of the sub-component signals may occur in computer chip(s) embedded in an oral device including the sensor(s) can be accomplished. Resulting data can either be transmitted as it becomes available via wired or wireless technology (such as Bluetooth) to a receiving device (such as a smartphone, a computer, or dedicated device) and/or uploaded to a receiving device at a later time. In other embodiments the multicomponent brain-based bio-signal is transmitted to an external receiving device (such as a smartphone, a computer, or dedicated device) for signal processing. The multicomponent brain-based bio-signal may be transmitted as it is being detected by the sensor or it may be recorded on a storage device in an oral device for retrieval at a later time.”).
The disclosure further associates the function “isolates at least one primary raw brain-based multicomponent electromagnetic bio-signal from a plurality of other subcomponents within the raw oral multicomponent electromagnetic bio-signal” and “configured to automatically determine a primary subcomponent brain-based bio-signal from a multi-component brain-based bio-signal” with processor 700 and an algorithm. See col. 6, lines 42-45, 48-50 and col. 7, lines 22-35 and 56-65. Thus, there is sufficient disclosure in the ‘493 Patent specification of an algorithm needed to transform the general purpose computer or microprocessor disclosed. Aristocrat, 521 F.3d 1328, 1333- 35 (Fed. Cir. 2008).
As to elements 2-6 above, “a computer processing unit” as claimed (“communicatively coupled to the at least two bio-signal sensors, …. send the raw oral multicomponent electromagnetic bio-signal to the computer processing unit, said computer processing unit includes an independent component analysis processor….a plurality of brain wave band pass filters that are configured to further separate the raw brain-based multicomponent signal into a plurality of frequency brain wave bands”) …”) is described in Fig. 10, EXTENAL [sic] UNIT: PROGRAMMED, col. 6, lines 42-50 (The external unit 650 includes a receiver unit 651, … an Independent Component Analysis (“ICA”) processor 700, a raw brain-based multicomponent bio-signal component analyzer 750,…, brain wave filters 1-N 751, 752 and 753”), col. 7, lines 34-35 (“the ICA processor 700 of a computer or Field Programmable Gate Array (FPGA).”), col. 8, lines 34-40 (“Following separation into individual subcomponent signals the raw brain-signal can be further analyzed or separated into various frequency bands using band-pass filters 750”), Fig. 15, element 650, col. 9, lines 18-24 (“FIG. 15 shows … an example of an oral attachment mouthguard 800 with electrodes … and transmission system, and an exemplary embodiment of the external unit 650. External unit can be a smartphone, computer or other computing device.”), col. 3, lines 28-36 (“a sensor in the oral cavity may be coupled to one or more electronic processors capable of electronically digitizing, amplifying, attenuating, filtering and normalizing the multi-component brain-based bio-signals as needed. The computer processor may also be capable of extracting, isolating or otherwise dividing sub-component signals from the multi-component brain-based bio-signals, and optionally classifying and analyzing the sub-component signals.”), Fig. 12, sentence bridging cols. 8-9 (“In some embodiments the internal oral unit 800 electronic circuits 601 that perform some or all of the functions described above.”) and col. 9, line 62-col. 10, line 10 (“In some embodiments, signal processing (including filtering, amplification, digitizing, storage etc.) and recording of some or all of the sub-component signals may occur in computer chip(s) embedded in an oral device including the sensor(s) can be accomplished. Resulting data can either be transmitted as it becomes available via wired or wireless technology (such as Bluetooth) to a receiving device (such as a smartphone, a computer, or dedicated device) and/or uploaded to a receiving device at a later time. In other embodiments the multicomponent brain-based bio-signal is transmitted to an external receiving device (such as a smartphone, a computer, or dedicated device) for signal processing. The multicomponent brain-based bio-signal may be transmitted as it is being detected by the sensor or it may be recorded on a storage device in an oral device for retrieval at a later time.”).
The disclosure states as to the functions (i.e. “to generate a command based on data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio-signal” (claims 7 and 10) and “to generate a diagnosis of a condition following comparing data from a brain wave band filtered from the at least one primary raw brain-based multicomponent bio signal to predetermined baseline data for diagnosis of the condition” (claims 8, 11 and 16 ) that “key feature information may be provided or displayed to a user/operator” and/or that key feature information “used to perform tasks, such as comparing an extracted subcomponent bio-signals to a database of baseline signals to control a device, assist in a diagnosis of a disease, disorder, or condition, and or report the status of the device function” and “[f]ollowing subcomponent bio-signal extraction, individual subcomponent bio-signals can be displayed or utilized for other purposes such as calculating vital signs, part of a command to control another device(s), or to perform additional processing such as extract particular features.” See 3:32-36 and 8:17-33. However, while the claims require “a computer processing unit’ for performing the above functions there is insufficient disclosure in the ‘493 Patent specification of an algorithm for performing the claimed specific computer function of elements 2-6 needed to transform the general purpose computer or microprocessor disclosed. Aristocrat, 521 F.3d 1328, 1333-35 (Fed. Cir. 2008).
As to element 9 above, “[the external device and] the at least one computer processor” as claimed is described in Fig. 10, EXTENAL [sic] UNIT: PROGRAMMED, col. 6, lines 42-50 (The external unit 650 includes a receiver unit 651, … an Independent Component Analysis (“ICA”) processor 700…”), col. 7, lines 34-35 (“the ICA processor 700 of a computer or Field Programmable Gate Array (FPGA).”), Fig. 15, element 650, col. 9, lines 18-24 (“FIG. 15 shows … an example of an oral attachment mouthguard 800 with electrodes … and transmission system, and an exemplary embodiment of the external unit 650. External unit can be a smartphone, computer or other computing device.”), col. 3, lines 28-36 (“a sensor in the oral cavity may be coupled to one or more electronic processors capable of electronically digitizing, amplifying, attenuating, filtering and normalizing the multi-component brain-based bio-signals as needed. The computer processor may also be capable of extracting, isolating or otherwise dividing sub-component signals from the multi-component brain-based bio-signals, and optionally classifying and analyzing the sub-component signals.”), Fig. 12, sentence bridging cols. 8-9 (“In some embodiments the internal oral unit 800 electronic circuits 601 that perform some or all of the functions described above.”) and col. 9, line 62-col. 10, line 10 (“In some embodiments, signal processing (including filtering, amplification, digitizing, storage etc.) and recording of some or all of the sub-component signals may occur in computer chip(s) embedded in an oral device including the sensor(s) can be accomplished. Resulting data can either be transmitted as it becomes available via wired or wireless technology (such as Bluetooth) to a receiving device (such as a smartphone, a computer, or dedicated device) and/or uploaded to a receiving device at a later time. In other embodiments the multicomponent brain-based bio-signal is transmitted to an external receiving device (such as a smartphone, a computer, or dedicated device) for signal processing. The multicomponent brain-based bio-signal may be transmitted as it is being detected by the sensor or it may be recorded on a storage device in an oral device for retrieval at a later time.”). However while the claims require “at least one computer processor”, in combination with an external device, for “display[ing] information for diagnosing” “sleep apnea”(claim 24), “a concussion” (claim 26), and “a seizure” (claim 28), respectively, in as much as the Examiner is able to ascertain (see paragraph 19 below), there is insufficient disclosure in the ‘493 Patent specification of an algorithm for performing the claimed specific computer function needed to transform the general purpose computer or microprocessor disclosed. Aristocrat, 521 F.3d 1328, 1333- 35 (Fed. Cir. 2008).
As to element 12, “a computer processing unit [communicatively coupled to the bio-signal sensors, wherein the bio-signal sensors are configured to detect a raw multicomponent electromagnetic bio-signal and send the raw multicomponent electromagnetic bio-signals to the computer processing unit, said computer processing unit] programmed to” and “[the plurality of electrodes and] the at least one computer processor” as claimed is described in Fig. 10, EXTENAL [sic] UNIT: PROGRAMMED, col. 6, lines 42-50 (“The external unit 650 includes a receiver unit 651, … an Independent Component Analysis (“ICA”) processor 700, a raw brain-based multicomponent bio-signal component analyzer 750,…, brain wave filters 1-N 751, 752 and 753”), col. 7, lines 34-35 (“the ICA processor 700 of a computer or Field Programmable Gate Array (FPGA).”), col. 8, lines 34-40 (“Following separation into individual subcomponent signals the raw brain-signal can be further analyzed or separated into various frequency bands using band-pass filters 750”), Fig. 15, element 650, col. 9, lines 18-24 (“FIG. 15 shows … an example of an oral attachment mouthguard 800 with electrodes … and transmission system, and an exemplary embodiment of the external unit 650. External unit can be a smartphone, computer or other computing device.”), col. 3, lines 28-36 (“a sensor in the oral cavity may be coupled to one or more electronic processors capable of electronically digitizing, amplifying, attenuating, filtering and normalizing the multi-component brain-based bio-signals as needed. The computer processor may also be capable of extracting, isolating or otherwise dividing sub-component signals from the multi-component brain-based bio-signals, and optionally classifying and analyzing the sub-component signals.”), Fig. 12, sent