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 .
Status of the Application
Preliminary amendment of 02/20/2024 has been acknowledged and entered.
Claims 1, 6 and 11-14 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statement filed 02/20/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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, 6 and 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandum of August 4, 2025.
Step 1
Claim 1 is directed to a statutory category, because a series of steps for etiologic screening satisfies the requirements of a process (a series of acts).
(Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Step 2A – Prong 1
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of etiologic screening of a sleep disorder. The claim recites:
1. A method for etiologic screening of a sleep disorder associated with micro-arousals, comprising:
identifying, in a first step, at least one of the following symptoms in a patient: Irritability, bad attitude, headache at awakening of the patient, dry mouth or throat at the awakening of the patient, anxiety, or heart palpitations while sleeping;
identifying, in a second step, if the patient has hypersomnia during the day that, wherein hypersomnia is> 8 on the Epworth sleepiness scale;
identifying, in a third step, if the patient has repetitive hypercaloric intake during the day due to chronic fatigue and exhaustion induced by the sleep disorder induces and if the patient has a BMI > 28 kg/m2;
identifying, in a fourth step, if the patient experiences exhaustion or fatigue in the afternoon or night;
identifying, in a fifth step, if the patient experiences snoring that converts into obstructive sleep apnea; and
identifying, in a sixth step, if the patient experiences fragmented sleep with an awakening index> 8.
Claim 1 does not recite the use of any technology at all. There is no machine-or-transformation in the claim, the recited steps could all be done mentally in a person's brain or on paper. However, technology is required to be considered statutory subject matter. The claim is not even arguably tied to a machine — especially under the Nuijten construction of machine to be a “concrete thing, consisting of parts, or of certain devices and combination of devices [including] every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.” (Quoting Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570 (1863)). For example, the claimed method could be implemented as a health practitioner observes sleeping patterns of a patient during sleep-apnea assessing session, and making notes regarding the observation results
On the second Bilski prong, the claim does not require transformation of any article into a different state or thing. The claims only recite an abstract idea. The recited steps do not apply, involve, use, or advance the technological arts since all of the recited steps can be done with no technology at all. The resulting structure could be a bunch of numbers and words on paper, which is not eligible for patent protection because it is simply printed matter. Therefore, claim 1 is not eligible subject matter under § 101.
For the purposes of examination, the Examiner assumes that the recited steps are performed by a processor.
The recited limitations is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity, such as following rules or instructions, but for the recitation of generic computer components. That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or certain methods of organizing human activity processes, and the mere nominal recitation of a generic network appliance (e.g. an interface for inputting or outputting data, or generic network-based storage devices and displays) does not take the claim limitation out of the mental processes and/or certain methods of organizing human activity grouping.
Specifically, regarding “identifying” steps, the utilizing statistical tools to process data and to output the estimated values - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, Mayo Collaborative Svcs. v. Prometheus Labs. 566 U.S. __, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012), - Optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders; Genetic Tech. Ltd. v. Merial LLC; 818 F.3d 1369, 118 U.S.P.Q.2d 1541 (Fed. Cir. 2016) - Intron sequence analysis method for detection of adjacent and remote locus alleles as haplotypes; In re Karpf; 611 Fed. Appx. 1005 (Fed. Cir. 2015); CAFC Appeal No. 14-1773 - Increasing patient compliance with medical care instructions; TLI Communications LLC v. AV Automotive LLC 823 F.3d 607, 118 U.S.P.Q.2d 1744 (Fed. Cir. 2016) - recording, transmitting and administering digital images; DataTreasury Corp. v. Fidelity National Information Services 669 Fed. Appx. 572 (Fed. Cir. 2016) - remote image capture with centralized processing and storage.
As per receiving, storing and outputting data limitations, it has been held that “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018) (citation omitted); see also In re Jobin, 811 F. App’x 633, 637 (Fed. Cir. 2020) (claims to collecting, organizing, grouping, and storing data using techniques such as conducting a survey or crowdsourcing recited a method of organizing human activity, which is a hallmark of abstract ideas).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 1, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that this judicial exception is not integrated into a practical application, because there are no meaningful limitations that transform the exception into a patent eligible application. In particular, the claim recites additional elements – using a processor to perform the identifying steps. However, the processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Thus, while the additional elements have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
The recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, storing, comparing and outputting data.
As per receiving, storing and/or outputting data limitations, these recitations amount to mere data gathering and/or outputting, is insignificant post-solution or extra-solution component and represents nominal recitation of technology. Insignificant "post-solution” or “extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. However, “(c) Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility”. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)). Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230.
Therefore, claim 1 as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).
The Examiner determined that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the identifying steps amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be construed at the highest level of generality. Based on the Specification [0050], the invention utilizes conventional sensors, communication networks and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity. Specifically, regarding the recited functions, MPEP 2106.05(d)(II) defines said functions as routine and conventional, or as insignificant extra-solution activity:
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) (“The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.”); collecting and comparing known information in Classen 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
iii. Electronic recordkeeping, Alice Corp., 134 S. Ct. at 2359, 110 USPQ2d at 1984 (creating and maintaining “shadow accounts”); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Below are examples of other types of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
i. Recording a customer’s order, Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1244, 120 USPQ2d 1844, 1856 (Fed. Cir. 2016);
iii. Restricting public access to media by requiring a consumer to view an advertisement, Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014);
iv. Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93;
v. Determining an estimated outcome and setting a price, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; and
vi. Arranging a hierarchy of groups, sorting information, eliminating less restrictive pricing information and determining the price, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. 2015).
Thus, the background of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here).
Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces, as asserted, by receiving information from an external source of data. The receiving of data from an external source over a network, such as via the Internet, can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular asserted inventive technology for performing those functions. They are therefore directed to an abstract idea. As such, the additional elements, considered individually and in combination with the other claim elements, do not make the claim as a whole significantly more than the abstract idea itself.
Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 1 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 1 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, storing, comparing and transmitting data—see the Specification as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. “However, it is not apparent how appellant’s programmed digital computer can produce any synergistic result. Instead, the computer will simply do the job it is instructed to do. Where is there any surprising or unexpected result? The unlikelihood of any such result is merely one more reason why patents should not be granted in situations where the only novelty is in the programming of general purpose digital computers”. See Sakraida v. Ag. Pro, Inc., 425 U.S. 273 [ 96 S.Ct. 1532, 47 L.Ed.2d 784], 189 USPQ 449 (1976) and A P Tea Co. V. Supermarket Corp., 340 U.S. 147 [ 71 S.Ct. 127, 95 L.Ed. 162], 87 USPQ 303 (1950).
Furthermore, there is no transformation recited in the claim as understood in view of 35 USC 101. The recited steps merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said identifying steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “by the processor” recitations, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 1 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claims 6 and 11-14 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 6 and 11-14 each merely add further details of the abstract steps recited in claim 1 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claims 6 and 11-14 are also directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2023/0148952 A1) in view of Lazarus et al. (US 2019/0008577 A1).
Claim 1. Gill et al. (Gill) discloses a method for etiologic screening of a sleep disorder associated with micro-arousals, comprising:
identifying, in a first step, at least one of the following symptoms in a patient: Irritability, bad attitude, headache at awakening of the patient, dry mouth or throat at the awakening of the patient, anxiety, or heart palpitations while sleeping; [0049]; [0051]
identifying, in a second step, if the patient has hypersomnia during the day that, wherein hypersomnia is> 8 on the Epworth sleepiness scale; (The sleepiness level can be determined and/or expressed in a variety of ways. For example, a sleepiness level can be a scaled value within a predetermined range (e.g., between 1 and 10) where the highest value is indicative of being very sleepy and the lowest is indicative of not being sleepy. [0222]
While Gill discloses considering BMI of the user [0221], Gill does not specifically teach identifying, in a third step, if the patient has repetitive hypercaloric intake during the day due to chronic fatigue and exhaustion induced by the sleep disorder, which is disclosed or suggested in Lazarus et al. (Lazarus). [0023]; [0030]; [0031]; [0053]; [0061]; [0106]; [0120]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modifyGill to include the recited limitations, as disclosed or suggested in Lazarus, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Gill, as modified by Lazarus, further teaches:
identifying, in a fourth step, if the patient experiences exhaustion or fatigue in the afternoon or night; [0051]; [0147]; [0149]; [0222]; [0228]
identifying, in a fifth step, if the patient experiences snoring that converts into obstructive sleep apnea; [0046]; [0070]; [0072]; [0073]; [0134], and
identifying, in a sixth step, if the patient experiences fragmented sleep with an awakening index> 8. (the fragmentation index is scaled between a predetermined range of integers (e.g., between 0 and 10)) [0072]; [0120]; [0124]
Claim 6. The method according to claim 1, further comprising: identifying, in the third step, if the patient has repetitive hypercaloric intake by also identifying if the patient experiences an urge or tendency to ingest hypercaloric foods. Gill, [0221]; Lazarus, [0023]; [0030]; [0031]; [0053]; [0061]; [0106]; [0120]. Same rationale as applied to claim 1.
Claim 11. The method according to claim 1, further comprising: treating the sleep disorder associated with micro-arousals by administering a therapeutically effective amount of benzodiazepines and nonbenzodiazepines. Lazarus, [0046]. Same rationale as applied to claim 1.
Claim 12. The method according to claim 11, further comprising: treating the sleep disorder associated with micro-arousals by co-administering an automatic positive airway pressure (APAP) using a mask on the patient for at least 3 to 8 weeks. Gill, [0058]; [0059]; [0060]; [0066]; Lazarus, [0114]. Same rationale as applied to claim 1.
Claim 13. The method according to claim 11, further comprising: utilizing a computing device for the identification in the first step, the second step, the third step, the fourth step, the fifth step, and the sixth step. Gill, Figs 1, 5A-16B. Same rationale as applied to claim 1.
Claim 14. The method according to claim 11, further comprising: treating the obstructive sleep apnea with a positive pressure device. Gill, [0058]; [0059]; [0060]; [0066]; Lazarus, [0114]. Same rationale as applied to claim 1.
Conclusion
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/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 12/05/2025