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 .
Specification
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). Correction of the following is required: “spectral filters”; “Daubechies wavelet order 4, level 3”; “power spectral density”. Each of these element is recited in the originally filed claims and have priority back to the originally filed claims in the parent application 13559116, but do not seem to be discussed in the specification.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities: claims 1 and 14 have been amended to recite “determining an indication of a seizure onset in response to a first determination that the ratio reaches an onset threshold”. However, the next element of initiating the electrical therapy based on “the seizure onset determination” has not been amended to reflect the change of the previous element, by including the “an indication of”. In view of the amendment, Examiner believes this to be an oversight and a typographical error and thus is including it as an objection instead of a clarity rejection. 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 limitation(s) is/are:
“a seizure onset/termination unit” in claims 10, 12 – see [0084] (using Pg Pub for paragraph numbers) including “The seizure onset/termination unit 280 may comprise software module(s) that are capable of performing various interface functions, filtering functions, etc. In another embodiment, the seizure onset/termination unit 280 may comprise hardware circuitry that is capable of performing these functions. In yet another embodiment, the seizure onset/termination unit 280 may comprise hardware, firmware, software and/or any combination thereof.”, [0085]-[0086], [0099]-[0100], Figs. 2, 5
“a time window control module” in claims 10, 12 - see [0084], [0089], [0100], Figs. 2, 5
“a spectral filter module” in claim 12 - see [0084] including “The seizure onset/termination unit 280 may comprise software module(s) that are capable of performing various interface functions, filtering functions, etc.”, Figs. 2, 5
“a ratio determination unit” in claim 12 - see [0084] including “The seizure onset/termination unit 280 may comprise software module(s) that are capable of performing various interface functions, filtering functions, etc.”, Figs. 2, 5
“a ratio threshold comparison unit” in claim 12 - see [0084] including “The seizure onset/termination unit 280 may comprise software module(s) that are capable of performing various interface functions, filtering functions, etc.”, Figs. 2, 5
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-4, 10-13, 16-17 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3-4, 10-13, 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Per MPEP 2161.01 "It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)" and "Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. ".
Claim 3, 10, 16 recite “wherein at least one parameter selected from the sliding foreground time window, the sliding background time window, the spectral filter, the onset threshold, or the termination threshold is selected based on at least one of:” (or claim 10 “time window control module uses parameters. . .”) and is followed by the list “a level of safety risk associated with an activity; at least one of an age, a physical state, or a mental state of the patient; a length of a window available for a warning; a degree of circadian and ultradian fluctuations of a patient's seizure activity; a performance of a detection method as a function of a patient's sleep/wake cycle or vigilance level; a dependence of a patient's seizure activity on at least one of a level of consciousness, a level of cognitive activity, or a level of physical activity; a site of a seizure origin; or a seizure type”. The specification recites a functional intent, to determine/set parameters, without disclosing how the intent is achieved. There does not appear to be adequate support for all of these variations, namely how one of the first group is selected based on one of the second. For example, there is only one mention of “sleep/wake cycle or vigilance level” see [0104] (using PG Pub for paragraph numbers), and it does disclose how this element occurs as claimed. The claims depending from these claims share this issue and are rejected for the same reasons. See the below portion of MPEP 2161.01.
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 10-13, 18 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 10 recites the limitation "the time window control module". There is insufficient antecedent basis for this limitation in the claim. There is no mention earlier in the claim of “a time window control module”, thus it is unclear what control module is being referenced. For the above reasons the claim does not clearly define the metes and bounds of what is claimed and is indefinite. The claims depending from this claim share this issue and are likewise indefinite.
Claim 12 recites “a time window control module” however in claim 10 it recites “the time window control module” which causes a lack of clarity. Is this the same time window control module or is it another time window control module? For the above reason the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim 18 recites the limitation "the second body signal". There is insufficient antecedent basis for this limitation in the claim. Neither claim 18 nor claim 14 from which claim 18 depends recites a second body signal (Examiner notes claim 14 did prior to the preliminary amendment). As such it is unclear what the metes and bounds of this claim are and the claim is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14, 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20050197590 to Osorio et al. (hereinafter Osorio).
Regarding Claim 14, an interpretation of Osorio discloses a non-transitory computer readable program storage unit encoded with instructions that, when executed by one or more medical devices, performs a method (abstract, [0087], [0090]), comprising:
receiving via the one or more medical devices a time series of a first body signal of a patient obtained from one or more sensors (Teaches an invention directed towards seizure detection based on obtained EEG or ECoG signal data and an output for prevention or abatement, or recording pertinent data, see abstract, [0088], Fig. 1);
determining a sliding foreground time window and a sliding background time window for the time series of the first body signal ([0043], [0064], Fig. 2);
applying a spectral filter to each of the sliding foreground time window and the sliding background time window (Teaches at Fig. 2 and paragraphs [0069], [0128] and [0140] using a finite impulse filter for detecting seizures in the signal data, wherein the FIR filter is considered to read on a broad and reasonable interpretation of a spectral filter. Teaches at paragraph [0128] and [0157] describing applying this filtering to moving foreground and background windows. Teaches at paragraph [0107]-[0108] describing calculating the power spectral density within ictal signals and between ictal (interictal) and using these for seizure detection, wherein the combination of using the impulse filtering and calculated power spectral densities reads on the step of applying a spectral filter having a defined power spectral density.);
determining a ratio of a spectral power between the sliding foreground time window and the sliding background time window (Teaches using a ratio between the windows and when the ratio reaches a particular threshold a seizure is signaled, see paragraph [0044]-[0045], [0069], [0107]);
determining an indication of a seizure onset in response to a first determination that the ratio reaches an onset threshold (describes using a ratio between the windows and when the ratio reaches a particular threshold a seizure is signaled, see paragraph [0044]-[0045], [0115]);
initiating an electrical therapy based on the seizure onset determination ([0024], [0040], [0089]-[0090]);
Regarding Claim 18, an interpretation of Osorio further discloses a second body signal comprises a measurement a patient's heart activity ([0032], [0093], [0118], [0121]).
Regarding Claim 19, an interpretation of Osorio further discloses initiating the electrical therapy by delivering the electrical therapy for the seizure at a particular time, the particular time is based upon the determination of the seizure onset ([0024], [0038], [0048], [0089]-[0090], [0133]; reference discloses starting electrical treatment immediately based on determinization of seizure onset); or issuing a warning for the seizure, wherein the warning is based upon the determination of the seizure onset ([0010], [0024], [0038], [0048], [0089], [0133]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10537251. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1, 5 and 13 of ‘251 are of slightly narrower scope than claims 1 and 14 of the current application thus read on those claims.
Claim 16 of ‘251 reads on claim 10 of the current application.
The dependent claims of ‘251 read on the dependent claims of the current application.
Claims 1-9, 14-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11672431. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1, 5 and 13 of ‘251 are of slightly narrower scope than claims 1 and 14 of the current application thus read on those claims.
Claim 16 of ‘431 reads on claim 10 of the current application.
The dependent claims of ‘431 read on claims 2, 4, 6-9, 15, 17-19 of the current application.
Claims 1-9, 14-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12226193. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 of ‘193 discloses claim 1 of the current application; Claims 1 and 8 of ‘193 disclose claim 14 of the current application thus read on those claims.
The dependent claims of ‘193 read on the dependent claims 2, 4, 6-9, 15, 17-19 of the current application.
Conclusion
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/James Moss/Examiner, Art Unit 3792
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