DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Drawings. The objections to the Drawings are withdrawn based on amendment to the specification and upon filing of replacement drawings.
Claim Objections. The objections to the claims are withdrawn based on amendment to claims.
Nonstatutory Double Patenting. Examiner acknowledges Applicant that a filing of a terminal disclaimer might be premature based on the status of claims, and that Applicant offers to submit a terminal disclaimer should the claims be otherwise allowable (Remarks p. 9).
35 USC 101. Applicant asserts that claim 1 has been amended more clearly to recite patentable subject matter including determining a zeitgeber for use in a circadian entrainment system and requires a network of coupled oscillators, wherein the network of coupled oscillators is structured to mimic a suprachiasmatic nucleus (SCN) response to light (remarks p. 9). Examiner respectfully disagrees. The above newly amended features merely generally line the abstract idea to a field of use, or technological environment and wherein the structure mimicking an SCN response flows directly from the abstract idea. See rejection below.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending U.S. Application 18912127. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of U.S. Application 18912127 would anticipate claims 1 of the present application. See representative claim mapping below.
17614985
18912127
1. A method for determining a zeitgeber for use in a circadian entrainment system to entrain an individual's circadian clock from a current circadian trajectory to or towards a target circadian trajectory that minimizes or reduces a cost function, the method comprising:
1. A method for determining a zeitgeber, K(t), for use in a circadian entrainment system to entrain an individual’s circadian clock from a current circadian trajectory, x(t), to or towards a target circadian trajectory, y(t), that minimizes or reduces a cost function C = C(x(t), y(t), K(t)), the method comprising:
(a) identifying an initial circadian state, x0;
(a) identifying an initial circadian state, x0;
(b) identifying a target circadian state trajectory, y(t);
(b) identifying the target circadian trajectory y(t);
(c) providing an initial zeitgeber, K0(t), at a time or over a time range;
(c) providing an initial zeitgeber, K0(t), and setting the zeitgeber K(t) = K0(t);
(d) stimulating a circadian state trajectory, x(t), in response to the initial zeitgeber K0(t), wherein the simulating comprises receiving at least one data set; (e) developing at least one zeitgeber history, K(t) using the at least one data set; (f)providing the data set to a network of coupled oscillators, wherein the network of coupled oscillators is structured to mimic a suprachiasmatic nucleus (SCN) response to light, the network of coupled oscillators, represented as nodes connected by edges, over a time period [ti, tj];
(d) simulating the current circadian trajectory x(t) in response to the initial zeitgeber K0(t); 4. The method of claim 1, wherein simulating the current circadian trajectory x(t) in response to the initial zeitgeber K0(t) comprises: (a) receiving at least one dataset; (b) developing at least one zeitgeber history, using the dataset; (c) providing the dataset to a network of coupled oscillators, represented as nodes connected by edges, over a time period [ti, tj]; and (d) using an output of the network of coupled oscillators for determining the global cost function.
(g) determining a cost function C=C(x(t), y(t), K(t)), over the same time or time range, for x(t); where C is the cost derived from x(t), y(t) and K(t), with K(t) being updated by;
(e) computing a global cost function, C(x(t), y(t), K0(t)), based on the simulation;
(i) providing lower and upper bounds for K(t); (ii) sampling components of K(t) within the lower and upper bounds; (iii) calculating the cost, C, from the circadian state trajectory, the target trajectory, and the zeitgeber, C(x(t), y(t), K(t)); (iv) interpolating the cost values at the sampled K(t) to identify possible locations of minima for C and ; (v) determining a new K(t) in identified minima locations at a denser resolution; and
(g) if the global cost function does not meet the set of convergence criteria, updating the zeitgeber K(t) based on the global cost function; (h) updating the global cost function based on the updated zeitgeber K(t); 8. The method of claim 4, wherein updating the zeitgeber K(t) based on the global cost function comprises: providing a lower bound for K(t); providing an upper bound for K(t); sampling components of K(t) within the lower bound and the upper bound, to derive a set of sampled components; calculating the global cost function using the set of sampled components, the current circadian trajectory x(t), the target circadian trajectory y(t), and the zeitgeber K(t); interpolating a set of cost values using the sampled components to identify possible locations of minima of the global cost function; updating K(t) in identified minima locations of the possible locations at a denser resolution; and repeating the interpolating using the denser resolution. 9. The method of claim 8, wherein the lower bound and the upper bound are set to be a minimum allowable time and a maximum allowable time, respectively, spent in either dark or light, with a first light duration, a first dark duration, a last light duration, and a last dark duration having no lower bounds, and wherein, for a specified activity, k, specified once every N hours, the lower bound is k * N and the upper bound is (k+1) * N.
(h) updating K(t) in response to C, repeating steps (d) through(g) until a convergence criteria is met.
(h) updating the global cost function based on the updated zeitgeber K(t); (i) iterating steps (g) and (h) until the global cost function meets the set of convergence criteria; and (j) providing the updated zeitgeber K(t) as the zeitgeber for use in the circadian entrainment system to entrain the individual’s circadian clock.
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 1-2, 4-10, and 12-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding claim 1, under the Alice Framework Step 1, claim 1 falls within the four statutory categories of patentable subject matter identified by 35 USC 101: a process, machine, manufacture, or a composition of matter.
Under the Alice Framework Step 2A prong 1, claim 1 recites mathematical concepts including mathematical relationships and mathematical calculations, and mental steps related minimizing a cost to approximately entrain a circadian state. Specifically, the claim recites the following mathematical relationships, mathematical calculations, and mental steps:
minimize or reduce a cost function,
(a) identifying an initial circadian state, x0;
(b) identifying a target circadian state trajectory, y(t);
(c) providing an initial zeitgeber, K0(t), at a time or over a time range;
(d) simulating a circadian state trajectory, x(t), in response the initial zeitgeber K0(t), wherein simulating comprises
(e) developing at least one zeitgeber history, K(t) using the at least one data set;
(f) represented as nodes connected by edges, over a time period [ti, tj];
(g) determining a cost function C = C(x(t), y(t), K(t)), over the same time or time range, for x(t); wherein C is the cost derived from x(t), y(t) and K(t), with K(t) being updated by:
(i) providing lower and upper bounds for K(t); (ii) sampling components of K(t) within the lower and upper bounds; (iii) calculating the cost, C, from the circadian state trajectory, the target trajectory, and the zeitgeber, C(x(t), y(t), K(t)); (iv) interpolating the cost values at the sampled K(t) to identify possible locations of minima for C; and (v) determining a new K(t) in identified minima locations at a denser resolution; and
(h) updating K(t) in response to C, repeating steps (d) through (g) until a convergence criteria is met.
Step (a) identifying an initial circadian state, x0 includes a mental step such as looking at a graph of a circadian trajectory plotted by value with respect to time and identifying a time t = 0 on the graph for the circadian state.
Step (b) identifying a target circadian state trajectory, y(t) includes a mental step such as looking at a graph or a series of potential graphs of a target circadian trajectory plotted by value with respect to time and identifying a plot as the target circadian state trajectory.
Step (c) providing an initial zeitgeber, K0(t), at a time or over a time range includes a mental step such as looking at a graph of values of K0(t) over time, and provide a value read or the entire graph.
Step (e) developing at least one zeitgeber history K(t) using the at least one data set includes the mental step of developing a history such as logging zeitgeber history K(t) with pen and paper.
The following steps comprise mathematical calculations and mathematical relationships:
(g) determining a cost function C = C(x(t), y(t), K(t)), over the same time or time range, for x(t); wherein C is the cost derived from x(t), y(t) and K(t), with K(t) being updated by (see specification p. 10 bottom – p. 12 middle):
(i) providing lower and upper bounds for K(t); (ii) within the lower and upper bounds; (iii) calculating the cost, C, from the circadian state trajectory, the target trajectory, and the zeitgeber, C(x(t), y(t), K(t)); (iv) interpolating the cost values at the sampled K(t) to identify possible locations of minima for C; (v) determining a new K(t) in identified minima locations at a denser resolution; and (h) updating K(t) in response to C, repeating steps (d) through (g) until a convergence criteria is met (see figures 5 and 6, and p. 12 bottom – 13 bottom).
For these reasons, claim 1 recites an abstract idea.
Under the Alice Framework Step 2A prong 2, the claim recites the additional elements: a method for determining a zeitgeber for use in a circadian entrainment system to entrain an individual’s circadian clock from a current circadian trajectory to or towards a target circadian trajectory, simulating a circadian state trajectory, x(t), in response to the initial zeitgeber K0(t), wherein the simulating comprises receiving at least one data set; providing the data set to a network of coupled oscillators, wherein the network of coupled oscillators is structure to mimic a suprachiasmatic nucleus (SCN) response to light, the network of oscillators structure to mimic a suprachiasmatic nucleus (SCN) response to light, the network of oscillators represented as nodes connected by edges, over a time period [ti,tj], and sampling components of K(t).The claim merely generally links the abstract idea to a particular technological environment, a network of coupled oscillators, represented as nodes and connected by edges, which simulates a circadian state trajectory, without claiming a specific structure of the network. Furthermore the method for use in a circadian entrainment system to entrain an individual’s circadian clock for a current circadian trajectory or towards a target circadian trajectory that minimizes or reduces a cost function, and the mimic of a SCN response to light merely recites and intended use, and recites a benefit that result directly from the abstract idea, not from a technological improvement. Furthermore receiving a data set, and sampling data comprises an insignificant extra solution activity. For these reasons, claim 1 is not integrated into a practical application.
Under the Step 2B analysis, the general linking to a particular technical environment, field of use, or intended result provides no inventive concept. Furthermore, the receiving a data set comprises well understood, routine, and conventional activity. See MPEP 2106.05(d).II.i. Furthermore, sampling data is well understood, routine, and conventional. See J.M. Cimbala, Digital Data Acquisition, Penn State University Lecture notes, 2014, p. 3 (hereinafter “Cimbala”). For these reasons, claim 1 does not amount to significantly more than the abstract idea.
Claims 2, 4-10, and 12-21 are rejected for at least the reasons set forth with respect to claim 1. Claims 2, 4, 6, 9-10, 12-14, 16-21 merely further mathematically limit the abstract set forth in claim 1. Claims 2, 4, 9-10, 12-14, and 16-21 recite no further additional elements that would require further analysis under Step 2A prong 2 and Step 2B.
Claim 5 recites the following further additional element: the parameters of the coupled oscillators are tuned using an autoencoder neural network. Under the step 2A prong 2 analysis, and step 2B analysis. the claim continues to merely generality link the use of the judicial exception to a particular technological environment, the autoencoder neural network for training. For these reasons claim 5 neither integrates into a practical application nor amounts to significantly more than an abstract idea.
Claim 7 recites the following further additional element: where the data set is a data set that includes at least one taken from: actigraphy data set, heart data set, light data set, and/or a temperature data set. Under the Step 2A prong 2 analysis the further limitation of the data set recites an insignificant extra solution activity. For this reason the claim is not integrated into a practical application. Under the Step 2B analysis this limitation is well understood, routine, and conventional. See MPEP 2106.05(d).II.i. For these reasons, claim 1 does not amount to significantly more than the abstract idea.
Claim 8 recites the following further additional element: the data set is provided by a wearable device. Under the step 2A prong 2 analysis, and step 2B analysis. the claim continues to merely generality link the use of the judicial exception to a field of use. For these reasons claim 8 neither integrates into a practical application nor amounts to significantly more than an abstract idea.
Claim 15 further mathematically limits claim 1 and recites the following further additional elements: sample from a range of possible zeitgebers. Under the Step 2A prong 2 analysis, this sampling data recites an insignificant extra solution activity. Under the Step 2B analysis, this limitation is well understood, routine, and conventional. See Cimbala p. 3. For these reasons, claim 15 does not amount to significantly more than the abstract idea.
Allowable Subject Matter
For the reasons set forth in the office action dated 04/18/25, claim 1 would be allowable if rewritten to overcome the nonstatutory double patenting objection or upon filing of a Terminal Disclaimer, and rewritten to overcome the rejection under 35 USC 101. Claims 2, 4-10, and 12-21 would be allowable if rewritten to overcome the rejections under 35 USC 101.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/EMILY E LAROCQUE/Primary Examiner, Art Unit 2182