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)(5) because they include the following reference character(s) not mentioned in the description:
-Figs. 1 and 2 contain element 103 which is not found within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities:
[0027] recites “eb implemented” should possibly be –be implemented—
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:
Claims 1 and 20 recites “a user interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is receiving two or more input parameters and displaying the change in the first input parameters. According to the specification the user interface includes a display, control panel [0027] and equivalents thereof.
Claims 10 recites “a communications interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is receiving one or more input parameters and displaying the change in the first input parameters. According to the specification the user interface includes a display, control panel [0027] and equivalents thereof.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “the receiving a second input parameter” in lines 17-18. There is insufficient antecedent basis for this limitation in the claim.
-Claim 10 recites “the communications user interface” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the communications interface—
-Claim 10 recites “the change in the first parameter” in lines 8-9, There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the change in the first input parameter—
-Claim 20 recites “the receiving a second input parameter” in lines 23-24. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a series of mental processes that can occur in the human mind. These mental processes include receiving input parameters, generating sleep parameters, generating stimulation parameters, making a determination based on the input parameters, displaying data and applying stimuli based on the data. This judicial exception is not integrated into a practical application because the processing device is recited as performing the generic computer function of collecting, determining and commanding the system to impart stimuli. Further, mere instructions or commands to apply a judicial exception using a generic processing device does not impose meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the receiving, generating and determining steps merely define the data that can be presented to the mind and the displaying and applying steps can be performed by hand (an individual manually adjustment of stimulus) based on the individual's analysis (the mental process). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in claims 1-20 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The recitation of sleep is not presented in a manner relevant to a medical condition since sleep is not necessarily a medical condition.
An analysis of the claims is shown below:
Step 1: Claims 1-9 are directed towards a method, which is a statutory category of invention.
Claims 10-19 are directed towards system, which is a statutory category of invention.
Claim 20 is directed towards an apparatus, which is a statutory category of invention.
Step 2A, prong 1: Claims 1-20 recite limitations that are directed to an abstract idea. These claims recite acquiring input, sleep, and stimulation parameter data, determining parameters for sleep and stimulation and changes in such categories and applying stimuli based on these determined parameters. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to analyze sleep and stimulation data as well to compute whether that data corresponds to changes in biomarkers. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping. Thus Claims 1-20 are directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claims 1-3 and 5-8 do not recite additional elements that integrate the judicial exception into a practical application. Claims 1 recite the following additional elements:
-processing device
-user interface/communication interface
-memory
The processing device, interface and memory components are generically recited at a high level of generality. Further mere instructions or commands to apply judicial exception using a generic processing device independently does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or
medical condition. While the bodies of these claims discuss application of stimuli, there is no claim limitation that recites a particular treatment method, stimulation apparatus or apparatus related to sleep. The recitation of sleep and electrical stimuli are not presented in a manner relevant to a medical condition since sleep and electrical stimuli do not necessarily encompass a medical condition.
Thus claims 1-20 do not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, claims 2-5, 7, 11-13, 16-19 further limit data types including mapping between inputs and targets in correlation with previous data, biomarker target data, and composition of biomarker data, and composition of sleep input data. Claims 6, 8, 14-15 further define changes in stimulation parameters, biomarkers and efficacy of such required data. Mere command to apply a judicial exception using a generic processing device does not impose meaningful limits on practicing the abstract idea. Furthermore, the processes and steps can be considered nonfunctional descriptive material because there are no elements that show how the processor interacts with other components (such as a stimulation device or sleep device) or fulfills the function of applying a stimuli within the system.
In reconsidering the additional elements of the method, the additional elements were determined to be well-understood, routine and conventional based on the following evidence:
-Chen (U.S. 20200105398) discloses a processing device [0027; “computer/processor”], memory [0027; “RAM, ROM”] and user interface [0018; “user interfaces”] in reference to a method for administering stimulations to a sleeping subject.
Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11938275. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the claims in the U.S. Patent encompasses the subject matter of the claims in the instant Application. Claims 1-19 have been provided in a table below to demonstrate the similarity between the claims of the instant Application and the claims in the U.S. Patent 11938275.
Claim
Instant Application 18/429,270
US Patent No. 11938275
Claim
1
A method, comprising:
receiving, via a user interface, two or more input parameters associated with a sleep profile of a user, the two or more input parameters representing at least one sleep profile target;
A method, comprising: receiving, via a user interface, two or more input parameters associated with a sleep profile of a user, the two or more input parameters representing at least one sleep profile target;
1
1
generating, using one or more processors of a processing device, a plurality of sleep parameters based, at least in part, on the received two or more input parameters, the plurality of sleep parameters representing two or more changes to two or more biomarkers of the user;
generating, using one or more processors of a processing device, a plurality of sleep parameters based, at least in part, on the received two or more input parameters, the plurality of sleep parameters representing two or more changes to two or more biomarkers of the user;
1
generating a plurality of stimulation parameters based, at least in part, on the plurality of sleep parameters, the plurality of stimulation parameters representing electrical stimuli to a user's brain configured to implement the two or more changes for each of the two or more biomarkers of the user;
generating a plurality of stimulation parameters based, at least in part, on the plurality of sleep parameters, the plurality of stimulation parameters representing electrical stimuli to a user's brain configured to implement the two or more changes for each of the two or more biomarkers of the user;
1
determining a trade-off in the two or more input parameters including a change in a first input parameter of the two or more input parameters based on the receiving a second input parameter of the two or more input parameters;
determining a trade-off in the two or more input parameters including a change in a first input parameter of the two or more input parameters based on the receiving a second input parameter of the two or more input parameters,
1
displaying, with the user interface, the change in the first input parameter;
displaying, with the user interface, the change in the first input parameter;
1
applying stimuli to the user based, at least in part, on the plurality of stimulation parameters.
applying stimuli to the user based, at least in part, on the plurality of stimulation parameters;
2
mapping the two or more input parameters to a plurality of target parameters, the plurality of target parameters identifying the two or more biomarkers of the user.
mapping the two or more input parameters to a plurality of target parameters, the plurality of target parameters identifying the two or more biomarkers of the user.
2
3
wherein the mapping is generated based, at least in part, on previous measurement data.
wherein the mapping is generated based, at least in part, on previous measurement data.
3
4
wherein the two or more changes represented by the plurality of sleep parameters are configured to identify target values for the two or more biomarkers.
wherein the two or more changes represented by the plurality of sleep parameters are configured to identify target values for the two or more biomarkers.
4
5
wherein the two or more biomarkers comprise a ratio of band activities and shifts in frequency spectra of activity.
wherein the two or more biomarkers comprise a ratio of band activities and shifts in frequency spectra of activity.
5
6
wherein the plurality of stimulation parameters is configured to change each of one or more current values of the two or more biomarkers to the identified target values of the two or more biomarkers.
wherein the plurality of stimulation parameters is configured to change each of one or more current values of the two or more biomarkers to the identified target values of the two or more biomarkers.
6
7
wherein the first input parameter is one of sleep quality, sleep latency, sleep onset and overall sleep efficiency.
wherein the sleep profile target includes sleep latency.
wherein the sleep profile target includes sleep quality.
wherein the sleep profile target includes sleep onset.
wherein the sleep profile target includes sleep stage onset latency.
8, 9, 10, 11
8
further comprising: generating a result object based, at least in part, on measurement data, the result object representing an efficacy of the plurality of stimulation parameters.
further comprising: generating a result object based, at least in part, on the measurement data, the result object representing an efficacy of the plurality of stimulation parameters.
7
9
wherein the efficacy of the plurality of stimulation parameters is determined based, at least in part, on the at least one sleep profile target.
wherein the efficacy of the plurality of stimulation parameters is determined based, at least in part, on the at least one sleep profile target.
8
Claims 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-24 of U.S. Patent No. 11938275 in view of Pradeep U.S. 11986649. Boldfaced claim limitations represent slight variances not explicitly covered by U.S. Patent No. 11986649. In view of the secondary reference, US Patent No. 11938275, the claims of the U.S. Application 11986649 meet the claim limitations set forth. NSDP-Obviousness Analysis rejections have been provided below the table.
10
A system comprising: a communications interface configured to receive one or more input parameters associated with a sleep profile of a user, the one or more input parameters representing at least one sleep profile target;
A system comprising: a communications interface configured to receive one or more input parameters associated with a sleep profile of a user, the one or more input parameters representing at least one sleep profile target;
19
10
a non-transitory memory storing thereon instructions to configure a processing device to:
a processing device configured to:
19
10
generate a plurality of sleep parameters based the received one or more input parameters, and the plurality of sleep parameters representing one or more changes to one or more biomarkers of the user;
generate a plurality of sleep parameters based the received one or more input parameters, and the plurality of sleep parameters representing one or more changes to one or more biomarkers of the user;
19
10
generate a plurality of stimulation parameters based, at least in part, on the plurality of sleep parameters, the plurality of stimulation parameters representing stimuli configured to implement the one or more changes for each of the one or more biomarkers of the user;
generate a plurality of stimulation parameters based, at least in part, on the plurality of sleep parameters, the plurality of stimulation parameters representing stimuli configured to implement the one or more changes for each of the one or more biomarkers of the user;
19
10
determine a trade-off in the one or more input parameters including a change in a first input parameter of the one or more input parameters based on receiving a second input parameter;
determine a trade-off in the one or more input parameters including a change in a first input parameter of the one or more input parameters based on receiving a second input parameter,
19
10
cause display on the communications user interface, the change in the first parameter; and
cause display on the communications user interface, the change in the first parameter;
19
10
cause application of stimuli to the user based, at least in part, on the plurality of stimulation parameters.
apply stimuli to the user based, at least in part, on the plurality of stimulation parameters;
19
11
wherein the processing device is further configured to: map the one or more input parameters to a plurality of target parameters, the plurality of target parameters identifying the one or more biomarkers of the user.
wherein the processing device is further configured to: map the one or more input parameters to a plurality of target parameters, the plurality of target parameters identifying the one or more biomarkers of the user.
20
12
wherein the one or more changes represented by the plurality of sleep parameters are configured to identify target values for the one or more biomarkers.
wherein the one or more changes represented by the plurality of sleep parameters are configured to identify target values for the one or more biomarkers.
21
13
wherein the plurality of stimulation parameters is configured to change each of one or more current values of the one or more biomarkers to the identified target values of the one or more biomarkers.
wherein the plurality of stimulation parameters is configured to change each of one or more current values of the one or more biomarkers to the identified target values of the one or more biomarkers.
22
14
wherein the processing device is further configured to: generate a result object based, at least in part, on measurement data, the result object representing an efficacy of the plurality of stimulation parameters.
wherein the processing device is further configured to: generate a result object based, at least in part, on the measurement data, the result object representing an efficacy of the plurality of stimulation parameters.
23
15
wherein the efficacy of the plurality of stimulation parameters is determined based, at least in part, on the at least one sleep profile target.
wherein the efficacy of the plurality of stimulation parameters is determined based, at least in part, on the at least one steep profile target.
24
16
wherein the first input parameter includes sleep quality.
wherein the sleep profile target includes sleep quality.
9
17
wherein the first input parameter includes sleep latency.
wherein the sleep profile target includes sleep latency.
8
18
wherein the first input parameter includes sleep onset.
wherein the sleep profile target includes sleep onset.
10
19
wherein the first input parameter includes overall sleep efficiency.
wherein the sleep profile target includes overall sleep efficiency.
15
Regarding claim 10, the claim is rejected on the grounds of nonstautory double patenting over claim 19 of U.S. Patent 11938275 in view of Pradeep U.S. Patent 11986649. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 encompasses the subject matter of the claim in the instant application. While claim 19 of the U.S. Patent 11938275 does not explicitly recite “a non-transitory memory storing thereon instructions,” U.S. Patent 11986649 discloses the non-transitory computer readable medium (col 34, line 21). It would have been obvious to one having ordinary skill in the art to include memory or similar media to provide storage for data and programs pertaining to the system as indicated in [Col 31, lines 27-33; “uses memory 1303 to store data and program instructions and maintain a local side cache. The program instructions may control the operation of an operating system and/or one or more applications, for example. The memory or memories may also be configured to store received metadata and batch requested metadata.”]
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/246,618 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the Copending US application encompass the subject matter of the claims in the instant application. The claims are verbatim with the exception of reciting “two or more input parameters” (instant Application) in comparison to “one or more input parameters” (Copending application).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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